Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-03-09 @ 12:22 PM
Study NCT ID:
NCT02253160
Status:
COMPLETED
Last Update Posted:
2015-09-24
First Post:
2014-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Evaluation of the Spectra Optia CMNC Collection Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ray.Goodrich@terumobct.com', 'phone': '303-232-6800', 'title': 'Raymond P. Goodrich, PhD, VP, Scientific and Clinical Affairs; Chief Science Officer - BBT', 'organization': 'Terumo BCT'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were captured per protocol from the first dose of G-CSF until final follow up, which was typically 1 day after the last CMNC Collection Procedure for a total of 7 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-collection', 'description': 'Subjects screened and received G-CSF.', 'otherNumAtRisk': 23, 'otherNumAffected': 22, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Spectra Optia', 'description': 'Subject who received Spectra Optia CMNC collection procedure.', 'otherNumAtRisk': 23, 'otherNumAffected': 13, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'COBE Spectra', 'description': 'Subjects who received COBE Spectra MNC collection procedure.', 'otherNumAtRisk': 22, 'otherNumAffected': 16, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Follow up', 'description': 'Subjects who completed cross-over design and were followed for at least 1 day.', 'otherNumAtRisk': 23, 'otherNumAffected': 2, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'hemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'hypoaesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'muscle spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'tension headach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'insomina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}, {'term': 'restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 23, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'CD34+ Collection Efficiency (CE1 %)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Assignment 1', 'description': "Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'OG001', 'title': 'Treatment Assignment 2', 'description': "COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}], 'classes': [{'title': 'Spectra Optia', 'categories': [{'measurements': [{'value': '87.7', 'spread': '20.18', 'groupId': 'OG000'}, {'value': '81.4', 'spread': '10.24', 'groupId': 'OG001'}]}]}, {'title': 'COBE Spectra', 'categories': [{'measurements': [{'value': '66.6', 'spread': '20.26', 'groupId': 'OG000'}, {'value': '65.8', 'spread': '6.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within 5 minutes upon completion of procedure', 'description': 'The primary endpoint is the CD34+ cell collection efficiency (CE) associated with the Mononuclear Cell (CMNC) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the CMNC collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'CD34+ Collection Efficiency (CE2 %)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Assignment 1', 'description': "Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'OG001', 'title': 'Treatment Assignment 2', 'description': "COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}], 'classes': [{'title': 'Spectra Optia', 'categories': [{'measurements': [{'value': '64.7', 'spread': '14.61', 'groupId': 'OG000'}, {'value': '59.6', 'spread': '6.17', 'groupId': 'OG001'}]}]}, {'title': 'COBE Spectra', 'categories': [{'measurements': [{'value': '47.0', 'spread': '14.86', 'groupId': 'OG000'}, {'value': '50.2', 'spread': '4.20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within 5 minutes upon completion of procedure', 'description': 'Comparison of collection efficiencies associated with the CMNC Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor blood counts immediately before and blood product blood counts immediately after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MNC Collection Efficiency (CE1%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Assignment 1', 'description': "Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'OG001', 'title': 'Treatment Assignment 2', 'description': "COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}], 'classes': [{'title': 'Spectra Optia CE1', 'categories': [{'measurements': [{'value': '62.06', 'spread': '17.220', 'groupId': 'OG000'}, {'value': '63.75', 'spread': '18.900', 'groupId': 'OG001'}]}]}, {'title': 'COBE Spectra CE1', 'categories': [{'measurements': [{'value': '45.46', 'spread': '6.483', 'groupId': 'OG000'}, {'value': '48.58', 'spread': '14.685', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within 5 minutes upon completion of procedure', 'description': 'Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated.'}, {'type': 'SECONDARY', 'title': 'CD34+ Per kg of Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Assignment 1', 'description': "Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'OG001', 'title': 'Treatment Assignment 2', 'description': "COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}], 'classes': [{'title': 'Spectra Optia', 'categories': [{'measurements': [{'value': '5.14', 'spread': '3.756', 'groupId': 'OG000'}, {'value': '3.75', 'spread': '1.506', 'groupId': 'OG001'}]}]}, {'title': 'COBE Spectra', 'categories': [{'measurements': [{'value': '3.50', 'spread': '2.732', 'groupId': 'OG000'}, {'value': '3.68', 'spread': '1.546', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within 5 minutes upon completion of procedure', 'unitOfMeasure': 'cells/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MNC Product Contamination/Purity (%) - Hematocrit (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Assignment 1', 'description': "Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'OG001', 'title': 'Treatment Assignment 2', 'description': "COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}], 'classes': [{'title': 'Spectra Optia Hematocrit', 'categories': [{'measurements': [{'value': '6.1', 'spread': '2.12', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.95', 'groupId': 'OG001'}]}]}, {'title': 'COBE Spectra Hematocrit', 'categories': [{'measurements': [{'value': '4.5', 'spread': '1.54', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '1.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within 5 minutes upon completion of procedure', 'unitOfMeasure': '% of red blood cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Assignment 1', 'description': "Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'OG001', 'title': 'Treatment Assignment 2', 'description': "COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}], 'classes': [{'title': 'Spectra Optia', 'categories': [{'measurements': [{'value': '51.689', 'spread': '35.5970', 'groupId': 'OG000'}, {'value': '63.338', 'spread': '44.9682', 'groupId': 'OG001'}]}]}, {'title': 'COBE Spectra', 'categories': [{'measurements': [{'value': '83.792', 'spread': '58.9491', 'groupId': 'OG000'}, {'value': '70.944', 'spread': '72.4223', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within 5 minutes upon completion of procedure', 'unitOfMeasure': 'cells*10^3/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Assignment 1', 'description': "Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'OG001', 'title': 'Treatment Assignment 2', 'description': "COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}], 'classes': [{'title': 'Spectra Optia', 'categories': [{'measurements': [{'value': '3724.9', 'spread': '962.42', 'groupId': 'OG000'}, {'value': '2022.9', 'spread': '674.91', 'groupId': 'OG001'}]}]}, {'title': 'COBE Spectra', 'categories': [{'measurements': [{'value': '2857.4', 'spread': '467.44', 'groupId': 'OG000'}, {'value': '3736.0', 'spread': '1200.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within 5 minutes upon completion of procedure', 'unitOfMeasure': 'cells*10^3/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Assignment 1', 'description': "Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'OG001', 'title': 'Treatment Assignment 2', 'description': "COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}], 'classes': [{'title': 'Spectra Optia', 'categories': [{'measurements': [{'value': '28.7', 'spread': '14.08', 'groupId': 'OG000'}, {'value': '23.5', 'spread': '8.62', 'groupId': 'OG001'}]}]}, {'title': 'COBE Spectra', 'categories': [{'measurements': [{'value': '27.9', 'spread': '9.19', 'groupId': 'OG000'}, {'value': '30.3', 'spread': '9.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within 5 minutes upon completion of procedure', 'description': 'Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for platelets. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was not included in MNC CE1 because of missing MNC lab results post-collection, therefore CE1 could not be calculated.'}, {'type': 'SECONDARY', 'title': 'MNC Blood Product Volume (mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Assignment 1', 'description': "Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'OG001', 'title': 'Treatment Assignment 2', 'description': "COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}], 'classes': [{'title': 'Spectra Optia', 'categories': [{'measurements': [{'value': '144.8', 'spread': '32.99', 'groupId': 'OG000'}, {'value': '141.3', 'spread': '30.82', 'groupId': 'OG001'}]}]}, {'title': 'COBE Spectra', 'categories': [{'measurements': [{'value': '140.8', 'spread': '28.36', 'groupId': 'OG000'}, {'value': '137.7', 'spread': '28.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within 5 minutes upon completion of procedure', 'description': 'The produced unit of MNCs collected into the blood bag.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Assignment 1', 'description': "Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'OG001', 'title': 'Treatment Assignment 2', 'description': "COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}], 'classes': [{'title': 'Spectra Optia', 'categories': [{'measurements': [{'value': '32.5', 'spread': '30.41', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '5.86', 'groupId': 'OG001'}]}]}, {'title': 'COBE Spectra', 'categories': [{'measurements': [{'value': '147.5', 'spread': '4.95', 'groupId': 'OG000'}, {'value': '179.3', 'spread': '72.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within 5 minutes upon completion of procedure', 'description': 'A small amount of plasma typically used for processing was collected in a sub-set of collection procedures.', 'unitOfMeasure': 'cells*10^3/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Five collections also collected plasma for this sub-study.'}, {'type': 'SECONDARY', 'title': 'Procedure Time (Minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Assignment 1', 'description': "Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'OG001', 'title': 'Treatment Assignment 2', 'description': "COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}], 'classes': [{'title': 'Spectra Optia', 'categories': [{'measurements': [{'value': '153.8', 'spread': '30.90', 'groupId': 'OG000'}, {'value': '151.4', 'spread': '27.55', 'groupId': 'OG001'}]}]}, {'title': 'COBE Spectra', 'categories': [{'measurements': [{'value': '151.1', 'spread': '31.92', 'groupId': 'OG000'}, {'value': '146.7', 'spread': '27.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within 5 minutes upon completion of procedure', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Device Deficiencies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Spectra Optia', 'description': 'Subjects who received an CMNC collection using the Spectra Optia'}, {'id': 'OG001', 'title': 'COBE Spectra', 'description': 'Subjects who received an CMNC collection using the COBE Spectra'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24-hours after last collection procedure', 'description': "Any time a device or disposable does not function as described in the Operator's Manual or Package Insert, a Device Deficiency must be reported. This includes those instances wherein Operator Error led to a malfunction/deficiency. A device deficiency is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer. Device malfunctions and device incidents should be reported in the same manner.", 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED', 'populationDescription': 'All pivotal subjects (n=22) received both the Spectra Optia and the COBE Spectra per the crossover design. The lead-in subject only received the Spectra Optia. Both lead-in and pivotal subjects are included in any safety analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Post-collection Platelet Loss in Subject', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Assignment 1', 'description': "Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'OG001', 'title': 'Treatment Assignment 2', 'description': "COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}], 'classes': [{'title': 'Spectra Optia', 'categories': [{'measurements': [{'value': '27.2', 'spread': '9.88', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '8.04', 'groupId': 'OG001'}]}]}, {'title': 'COBE Spectra', 'categories': [{'measurements': [{'value': '27.2', 'spread': '9.42', 'groupId': 'OG000'}, {'value': '30.7', 'spread': '6.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24-hours after last collection procedure', 'description': 'The percent change from pre-collection platelet count to post-collection subject platelet count.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MNC Collection Efficiency (CE2%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Assignment 1', 'description': "Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'OG001', 'title': 'Treatment Assignment 2', 'description': "COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}], 'classes': [{'title': 'Spectra Optia CE2', 'categories': [{'measurements': [{'value': '50.99', 'spread': '16.590', 'groupId': 'OG000'}, {'value': '52.98', 'spread': '17.528', 'groupId': 'OG001'}]}]}, {'title': 'COBE Spectra CE2', 'categories': [{'measurements': [{'value': '37.77', 'spread': '5.297', 'groupId': 'OG000'}, {'value': '39.72', 'spread': '13.972', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within 5 minutes upon completion of procedure', 'description': 'Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE2 is a measurement of device performance calculated using donor blood counts immediately before and blood product counts immediately after the collection procedure and does not average the donor pre- and post-collection counts. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MNC Product Contamination/Purity - RBC Concentration (10^6/µL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Assignment 1', 'description': "Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'OG001', 'title': 'Treatment Assignment 2', 'description': "COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}], 'classes': [{'title': 'Spectra Optia RBC Concentration', 'categories': [{'measurements': [{'value': '1.029', 'spread': '0.4740', 'groupId': 'OG000'}, {'value': '0.526', 'spread': '0.1990', 'groupId': 'OG001'}]}]}, {'title': 'COBE Spectra RBC Concentration', 'categories': [{'measurements': [{'value': '0.653', 'spread': '0.2786', 'groupId': 'OG000'}, {'value': '0.857', 'spread': '0.2501', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within 5 minutes upon completion of procedure', 'unitOfMeasure': 'RBC*10^6/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lead-in Donor', 'description': 'Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.'}, {'id': 'FG001', 'title': 'Spectra Optia CMNC First, Then COBE Spectra MNC', 'description': "Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'FG002', 'title': 'COBE Spectra MNC First, Then Spectra Optia CMNC', 'description': "COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited from the specialized donor population of blood centers from August 2014 through January 2015.', 'preAssignmentDetails': 'A lead-in phase was used to allow for investigational device training. One subject consented the lead-in phase and was included in the safety analysis only. After a screening period to evaluate and confirm eligibility criteria prior to enrollment \\& randomization to treatment assignment (Arm 1 or Arm 2) 22 subjects enrolled in the pivotal study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Lead-in Donor', 'description': 'Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.'}, {'id': 'BG001', 'title': 'Spectra Optia CMNC First, Then COBE Spectra MNC', 'description': "Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'BG002', 'title': 'COBE Spectra MNC First, Then Spectra Optia CMNC', 'description': "COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.\n\nSpectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.\n\nCOBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': 'NA', 'comment': 'no s.d. available when n=1', 'groupId': 'BG000'}, {'value': '35.4', 'spread': '7.32', 'groupId': 'BG001'}, {'value': '34.8', 'spread': '8.44', 'groupId': 'BG002'}, {'value': '35.0', 'spread': '7.51', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '110', 'spread': 'NA', 'comment': 'no s.d. available when n=1', 'groupId': 'BG000'}, {'value': '115.23', 'spread': '28.921', 'groupId': 'BG001'}, {'value': '97.08', 'spread': '26.654', 'groupId': 'BG002'}, {'value': '107.11', 'spread': '28.124', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '60', 'spread': 'NA', 'comment': 'no s.d. available when n=1', 'groupId': 'BG000'}, {'value': '70.8', 'spread': '2.45', 'groupId': 'BG001'}, {'value': '69.4', 'spread': '4.06', 'groupId': 'BG002'}, {'value': '69.7', 'spread': '3.83', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'inches', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '47.36', 'spread': 'NA', 'comment': 'no s.d. available when n=1', 'groupId': 'BG000'}, {'value': '35.82', 'spread': '9.413', 'groupId': 'BG001'}, {'value': '30.88', 'spread': '6.050', 'groupId': 'BG002'}, {'value': '34.17', 'spread': '8.579', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Healthy adult specialized blood donors'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-24', 'studyFirstSubmitDate': '2014-09-23', 'resultsFirstSubmitDate': '2015-05-05', 'studyFirstSubmitQcDate': '2014-09-26', 'lastUpdatePostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-24', 'studyFirstPostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Device Deficiencies', 'timeFrame': '24-hours after last collection procedure', 'description': "Any time a device or disposable does not function as described in the Operator's Manual or Package Insert, a Device Deficiency must be reported. This includes those instances wherein Operator Error led to a malfunction/deficiency. A device deficiency is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in the information supplied by the manufacturer. Device malfunctions and device incidents should be reported in the same manner."}, {'measure': 'Post-collection Platelet Loss in Subject', 'timeFrame': '24-hours after last collection procedure', 'description': 'The percent change from pre-collection platelet count to post-collection subject platelet count.'}], 'primaryOutcomes': [{'measure': 'CD34+ Collection Efficiency (CE1 %)', 'timeFrame': 'within 5 minutes upon completion of procedure', 'description': 'The primary endpoint is the CD34+ cell collection efficiency (CE) associated with the Mononuclear Cell (CMNC) Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the CMNC collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.'}], 'secondaryOutcomes': [{'measure': 'CD34+ Collection Efficiency (CE2 %)', 'timeFrame': 'within 5 minutes upon completion of procedure', 'description': 'Comparison of collection efficiencies associated with the CMNC Cell Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems. CE is a measurement of device performance calculated using donor blood counts immediately before and blood product blood counts immediately after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.'}, {'measure': 'MNC Collection Efficiency (CE1%)', 'timeFrame': 'within 5 minutes upon completion of procedure', 'description': 'Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.'}, {'measure': 'CD34+ Per kg of Body Weight', 'timeFrame': 'within 5 minutes upon completion of procedure'}, {'measure': 'MNC Product Contamination/Purity (%) - Hematocrit (%)', 'timeFrame': 'within 5 minutes upon completion of procedure'}, {'measure': 'MNC Product Contamination/Purity (%) - Granulocyte Concentration (10^3/mL)', 'timeFrame': 'within 5 minutes upon completion of procedure'}, {'measure': 'MNC Product Contamination/Purity (%) - Platelet Concentration (10^3/µL)', 'timeFrame': 'within 5 minutes upon completion of procedure'}, {'measure': 'MNC Product Contamination/Purity (%) - Platelet Collection Efficiency (CE1 %)', 'timeFrame': 'within 5 minutes upon completion of procedure', 'description': 'Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for platelets. CE1 is a measurement of device performance calculated using donor and blood product blood counts collected immediately before and after the collection procedure. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.'}, {'measure': 'MNC Blood Product Volume (mL)', 'timeFrame': 'within 5 minutes upon completion of procedure', 'description': 'The produced unit of MNCs collected into the blood bag.'}, {'measure': 'Purity of Plasma Collected for Laboratory Processing of MNC Product - Platelet Concentration in Plasma (10^3/µL)', 'timeFrame': 'within 5 minutes upon completion of procedure', 'description': 'A small amount of plasma typically used for processing was collected in a sub-set of collection procedures.'}, {'measure': 'Procedure Time (Minutes)', 'timeFrame': 'within 5 minutes upon completion of procedure'}, {'measure': 'MNC Collection Efficiency (CE2%)', 'timeFrame': 'within 5 minutes upon completion of procedure', 'description': 'Comparison of collection efficiencies associated with the CMNC Collection Procedures on the Spectra Optia and COBE Spectra Apheresis Systems for MNCs. CE2 is a measurement of device performance calculated using donor blood counts immediately before and blood product counts immediately after the collection procedure and does not average the donor pre- and post-collection counts. The collection efficiency for a given cell type is defined as the percent of processed cells of that cell type that are in fact collected.'}, {'measure': 'MNC Product Contamination/Purity - RBC Concentration (10^6/µL)', 'timeFrame': 'within 5 minutes upon completion of procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MNCs', 'Mononuclear Cells', 'Apheresis', 'Spectra Optia'], 'conditions': ['Healthy Apheresis Donors', 'Mononuclear (MNC) Cell Donors']}, 'descriptionModule': {'briefSummary': "The purpose of this prospective, randomized, cross-over, multi-center study is to evaluate the performance of the Spectra Optia Apheresis System's CMNC Collection Procedure, compared to the COBE Spectra Apheresis System's MNC Procedure in mobilized healthy donors. Subject safety will be evaluated beginning with mobilization, throughout the collection procedure and for the day following the last collection.", 'detailedDescription': "This is a prospective, randomized, cross-over, multi-center study to evaluate the performance of the Spectra Optia system's CMNC Collection Procedure, compared to the COBE Spectra system's MNC Procedure in mobilized healthy donors.\n\nUp to 60 subject may be consented to meet the the enrollment target of 20 complete subjects. Eligible subjects will be randomized to receive either the Spectra Optia CMNC or the COBE Spectra MNC collection procedure first, followed by the opposite on the following day.\n\nStudy participation will be up to 14 days: a 7-day screening period, four days for mobilization, one day for the first MNC collection with additional dose of mobilization, one day for the second MNC collection, and safety follow-up the following day.\n\nSubject safety will be evaluated beginning with mobilization, throughout the collection procedure and for the day following the second collection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 18 and ≤ 50 years of age\n2. Healthy blood donor criteria as defined by the American Associate of Blood Banks (AABB)\n\n a) Note: Subjects who are deferred from volunteer donations because of travel restrictions, piercings or tattoos may participate in the study\n3. Adequate dual peripheral venous access\n4. Acceptable prescreening laboratory results prior to MNC mobilization as specified below:\n\n a) WBC 3,500 - 10,800/µL\n\n b) Hematocrit 38% - 56%\n\n c) Platelets 150,000 - 400,000/µL\n\n d) Coagulation tests:\n\n i. PT 9.0 - 13.0 seconds\n\n ii. PTT 23.4 - 41.8 seconds\n\n e) Serum electrolytes:\n\n i. Potassium 3.6 - 5.1 mmol/L\n\n ii. Serum Calcium 8.5 mg/dL - 10.3 mg/dL\n\n f) Renal function: Serum creatinine ≤ 1.5 mg/dL\n\n NOTE: up to two laboratory results may fall out of the ranges listed above if, in the judgment of the investigator, they do not constitute a significant risk to the subject.\n5. Liver function: alanine aminotransferase (ALT) \\< 1.5 times the upper limit of normal\n6. Willing to avoid pregnancy until at least 48 hours following last G-CSF injection\n\n 1. If male, be willing to use a condom during sexual relations with a female partner until 48 hours following the last G-CSF injection\n 2. If female and of childbearing potential, be willing to use a medically acceptable contraceptive until 48 hours following the last G-CSF injection\n7. Given written informed consent\n\nExclusion Criteria:\n\n1. Previous MNC collection failure\n2. Known hypersensitivity or condition that prevents the use of anticoagulants\n3. Known hypersensitivity or condition that prevents the use of G-CSF\n4. Known hemoglobinopathy including sickle cell trait or disease\n5. History of use in the past week or anticipated need for lithium\n6. Concurrent enrollment in another clinical study that could impact the results or participation in this study\n7. Active infection or any serious underlying medical condition that contraindicates apheresis\n8. Women who are pregnant or lactating\n9. Known history of significant head trauma'}, 'identificationModule': {'nctId': 'NCT02253160', 'acronym': 'CMNC', 'briefTitle': 'An Evaluation of the Spectra Optia CMNC Collection Procedure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Terumo BCT'}, 'officialTitle': 'A Randomized, Crossover Trial to Characterize the Performance of the Spectra Optia Apheresis System Versus the COBE Spectra Apheresis System for Collection of Mononuclear Cells in Healthy Adult Donors', 'orgStudyIdInfo': {'id': 'CTS-5038'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spectra Optia CMNC first, then COBE Spectra MNC', 'description': 'Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.', 'interventionNames': ['Device: Spectra Optia CMNC', 'Device: COBE Spectra MNC', 'Drug: Granulocyte-colony stimulating factor (G-CSF)']}, {'type': 'EXPERIMENTAL', 'label': 'COBE Spectra MNC first, then Spectra Optia CMNC', 'description': 'COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.', 'interventionNames': ['Device: Spectra Optia CMNC', 'Device: COBE Spectra MNC', 'Drug: Granulocyte-colony stimulating factor (G-CSF)']}], 'interventions': [{'name': 'Spectra Optia CMNC', 'type': 'DEVICE', 'otherNames': ['Spectra Optia Apheresis System CMNC collection procedure'], 'description': "The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.", 'armGroupLabels': ['COBE Spectra MNC first, then Spectra Optia CMNC', 'Spectra Optia CMNC first, then COBE Spectra MNC']}, {'name': 'COBE Spectra MNC', 'type': 'DEVICE', 'otherNames': ['COBE Spectra Apheresis System MNC collection procedure'], 'description': 'It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.', 'armGroupLabels': ['COBE Spectra MNC first, then Spectra Optia CMNC', 'Spectra Optia CMNC first, then COBE Spectra MNC']}, {'name': 'Granulocyte-colony stimulating factor (G-CSF)', 'type': 'DRUG', 'otherNames': ['Mobilization Procedure'], 'description': 'Each subject received an injection of the G-CSF approximately equivalent to 10 ug/kg body weight subcutaneous per day for 5 days prior to the MNC collection procedure.', 'armGroupLabels': ['COBE Spectra MNC first, then Spectra Optia CMNC', 'Spectra Optia CMNC first, then COBE Spectra MNC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45267-0055', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hoxworth Blood Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Key Biologics, LLC', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Raymond Goodrich, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Terumo BCT'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Terumo BCT', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}