Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-02-21 @ 1:55 AM
Study NCT ID:
NCT00526058
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2007-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kevin.minnich@bbraun.com', 'phone': '610-596-2358', 'title': 'Kevin Minnich, Manager Clinical Affairs/Safety Officer', 'organization': 'B. Braun Medical Inc.'}, 'certainAgreement': {'otherDetails': "The Site may publish its own results of the FUTURA Trial after a cooperative publication or 12 months after Sponsor's final evaluation of all the FUTURA Trial data from all sites, whichever occurs first. At least 90 days prior to submitting a manuscript to a publisher or other outside persons or prior to any public presentation, a copy of the abstract, manuscript, or presentation will be provided to Sponsor for review and comment. Sponsor shall have said 90 day period to respond w/ comment.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Secura', 'description': 'Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.', 'otherNumAtRisk': 18, 'otherNumAffected': 15, 'seriousNumAtRisk': 18, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Futura', 'description': 'Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.', 'otherNumAtRisk': 18, 'otherNumAffected': 17, 'seriousNumAtRisk': 18, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Myocardial Ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'arteriovenous fistula occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'arteriovenous fistula site complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'arteriovenous fistula site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'device failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'medical device complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'breath sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'serum ferritin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'skin cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'nasal mucosal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'nasal oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'throat tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'seriousEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Endocrine disorders'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Myocardial Ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Pre- and Post-treatment Reductions of Low-density Lipoprotein Cholesterol (LDL-C) Levels Between the Approved H.E.L.P. System and the Modified H.E.L.P. System.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secura', 'description': 'Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)'}, {'id': 'OG001', 'title': 'Futura', 'description': 'Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)'}], 'classes': [{'categories': [{'measurements': [{'value': '55.28', 'groupId': 'OG000', 'lowerLimit': '38.6', 'upperLimit': '71.9'}, {'value': '52.89', 'groupId': 'OG001', 'lowerLimit': '33.3', 'upperLimit': '64.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples for LDL-cholesterol determination will be obtained before and after each treatment from week 0 to week 24..', 'unitOfMeasure': 'percent change', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Change of the Pre and Post Treatment Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secura', 'description': 'Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)'}, {'id': 'OG001', 'title': 'Futura', 'description': 'Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)'}], 'classes': [{'categories': [{'measurements': [{'value': '55.28', 'spread': '9.783', 'groupId': 'OG000'}, {'value': '52.89', 'spread': '8.228', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Noninferiority of the Futura system to the Secura system would be demonstrated if the upper bound of the 90% confidence interval (CI) for the difference between the two systems (Secura-Futura) in percent change of LDL-C measurements from pre- to post-treatment is less than the noninferiority margin 5.7%.'}], 'paramType': 'MEAN', 'timeFrame': 'Assessment based on LDL-C values obtained pre-and post-treatment, analyzed from week 0 to week 24.', 'description': 'The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements. Blood samples for LDL-cholesterol determination will be obtained before and after each treatment. The pooled difference between the pre- and post-treatment LDL level for each apheresis machine will be reported as the primary endpoint for the system performance.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Lab Profiles (Pre- and Post-Treatment)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secura', 'description': 'Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)'}, {'id': 'OG001', 'title': 'Futura', 'description': 'Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)'}], 'classes': [{'title': 'Total Triglycerides', 'categories': [{'measurements': [{'value': '63.17', 'groupId': 'OG000', 'lowerLimit': '40.1', 'upperLimit': '77.1'}, {'value': '71.46', 'groupId': 'OG001', 'lowerLimit': '40.8', 'upperLimit': '89.4'}]}]}, {'title': 'Total Cholesterol', 'categories': [{'measurements': [{'value': '50.23', 'groupId': 'OG000', 'lowerLimit': '40.4', 'upperLimit': '62.0'}, {'value': '48.12', 'groupId': 'OG001', 'lowerLimit': '34.6', 'upperLimit': '59.4'}]}]}, {'title': 'HDL-C', 'categories': [{'measurements': [{'value': '11.82', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '19.2'}, {'value': '7.41', 'groupId': 'OG001', 'lowerLimit': '-3.8', 'upperLimit': '15.4'}]}]}, {'title': 'VLDL-C', 'categories': [{'measurements': [{'value': '62.14', 'groupId': 'OG000', 'lowerLimit': '16.5', 'upperLimit': '76.3'}, {'value': '62.65', 'groupId': 'OG001', 'lowerLimit': '-13.2', 'upperLimit': '89.2'}]}]}, {'title': 'Lipoprotein (a)', 'categories': [{'measurements': [{'value': '59.25', 'groupId': 'OG000', 'lowerLimit': '43.5', 'upperLimit': '74.4'}, {'value': '49.68', 'groupId': 'OG001', 'lowerLimit': '-19.5', 'upperLimit': '74.1'}]}]}, {'title': 'Fibrinogen', 'categories': [{'measurements': [{'value': '54.81', 'groupId': 'OG000', 'lowerLimit': '38.0', 'upperLimit': '70.8'}, {'value': '52.00', 'groupId': 'OG001', 'lowerLimit': '30.9', 'upperLimit': '61.4'}]}]}, {'title': 'C-Reactive Protein', 'categories': [{'measurements': [{'value': '58.59', 'groupId': 'OG000', 'lowerLimit': '45.2', 'upperLimit': '67.7'}, {'value': '48.88', 'groupId': 'OG001', 'lowerLimit': '35.0', 'upperLimit': '59.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Analyzed at specific time points throughout the study from week 0 to week 24.', 'description': 'Changes in pre- and post-treatment levels of total cholesterol, high-density lipoprotein cholesterol (HDL-C), total triglycerides, lipoprotein (a), fibrinogen, and C-reactive protein.', 'unitOfMeasure': 'percent change', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for all 18 subjects; regardless of treatment sequence'}, {'type': 'SECONDARY', 'title': 'Device Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Secura', 'description': 'Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)'}, {'id': 'OG001', 'title': 'Futura', 'description': 'Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)'}], 'classes': [{'title': 'Start of Session; Session 1', 'categories': [{'measurements': [{'value': '27.11', 'spread': '9.380', 'groupId': 'OG000'}, {'value': '12.39', 'spread': '5.203', 'groupId': 'OG001'}]}]}, {'title': 'Start of Session; Session 2', 'categories': [{'measurements': [{'value': '23.41', 'spread': '10.978', 'groupId': 'OG000'}, {'value': '8.89', 'spread': '4.310', 'groupId': 'OG001'}]}]}, {'title': 'Start of Session; Session 3', 'categories': [{'measurements': [{'value': '28.00', 'spread': '13.711', 'groupId': 'OG000'}, {'value': '9.67', 'spread': '3.664', 'groupId': 'OG001'}]}]}, {'title': 'Start of Session; Session 4', 'categories': [{'measurements': [{'value': '26.35', 'spread': '8.838', 'groupId': 'OG000'}, {'value': '9.17', 'spread': '5.079', 'groupId': 'OG001'}]}]}, {'title': 'Start of Session; Session 5', 'categories': [{'measurements': [{'value': '26.29', 'spread': '6.049', 'groupId': 'OG000'}, {'value': '10.12', 'spread': '3.998', 'groupId': 'OG001'}]}]}, {'title': 'Start of Session; Session 6', 'categories': [{'measurements': [{'value': '27.61', 'spread': '7.920', 'groupId': 'OG000'}, {'value': '8.39', 'spread': '3.898', 'groupId': 'OG001'}]}]}, {'title': 'After 500mL; Session 1', 'categories': [{'measurements': [{'value': '33.67', 'spread': '6.380', 'groupId': 'OG000'}, {'value': '23.44', 'spread': '2.895', 'groupId': 'OG001'}]}]}, {'title': 'After 500mL; Session 2', 'categories': [{'measurements': [{'value': '32.59', 'spread': '5.938', 'groupId': 'OG000'}, {'value': '22.50', 'spread': '3.552', 'groupId': 'OG001'}]}]}, {'title': 'After 500mL; Session 3', 'categories': [{'measurements': [{'value': '31.61', 'spread': '4.354', 'groupId': 'OG000'}, {'value': '22.71', 'spread': '3.601', 'groupId': 'OG001'}]}]}, {'title': 'After 500mL; Session 4', 'categories': [{'measurements': [{'value': '32.11', 'spread': '3.216', 'groupId': 'OG000'}, {'value': '23.11', 'spread': '4.861', 'groupId': 'OG001'}]}]}, {'title': 'After 500mL; Session 5', 'categories': [{'measurements': [{'value': '34.67', 'spread': '5.018', 'groupId': 'OG000'}, {'value': '21.41', 'spread': '3.501', 'groupId': 'OG001'}]}]}, {'title': 'After 500mL; Session 6', 'categories': [{'measurements': [{'value': '32.72', 'spread': '8.456', 'groupId': 'OG000'}, {'value': '23.72', 'spread': '2.967', 'groupId': 'OG001'}]}]}, {'title': 'End of session; Session 1', 'categories': [{'measurements': [{'value': '26.24', 'spread': '16.510', 'groupId': 'OG000'}, {'value': '32.24', 'spread': '17.922', 'groupId': 'OG001'}]}]}, {'title': 'End of session; Session 2', 'categories': [{'measurements': [{'value': '27.87', 'spread': '16.587', 'groupId': 'OG000'}, {'value': '28.44', 'spread': '8.748', 'groupId': 'OG001'}]}]}, {'title': 'End of session; Session 3', 'categories': [{'measurements': [{'value': '19.17', 'spread': '15.946', 'groupId': 'OG000'}, {'value': '26.44', 'spread': '9.281', 'groupId': 'OG001'}]}]}, {'title': 'End of session; Session 4', 'categories': [{'measurements': [{'value': '28.00', 'spread': '15.326', 'groupId': 'OG000'}, {'value': '23.29', 'spread': '7.928', 'groupId': 'OG001'}]}]}, {'title': 'End of session; Session 5', 'categories': [{'measurements': [{'value': '30.28', 'spread': '12.750', 'groupId': 'OG000'}, {'value': '21.50', 'spread': '10.671', 'groupId': 'OG001'}]}]}, {'title': 'End of session; Session 6', 'categories': [{'measurements': [{'value': '28.59', 'spread': '15.133', 'groupId': 'OG000'}, {'value': '29.06', 'spread': '5.043', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Analyzed at specific time points throughout the study from week 0 to week 24.', 'description': 'Comparison of plasma flow rate recorded with both systems before treatment, after 500 mL of plasma treated, and at the end of each treatment session.', 'unitOfMeasure': 'flow rate (mL/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data for all 18 subjects; regardless of treatment sequence'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Secura', 'description': 'Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.'}, {'id': 'FG001', 'title': 'Futura', 'description': 'Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.'}], 'periods': [{'title': 'Period: First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period: Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Secura', 'description': 'Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.'}, {'id': 'BG001', 'title': 'Futura', 'description': 'Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.0', 'spread': '7.76', 'groupId': 'BG000'}, {'value': '59.7', 'spread': '9.15', 'groupId': 'BG001'}, {'value': '58.3', 'spread': '8.35', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-17', 'studyFirstSubmitDate': '2007-09-05', 'resultsFirstSubmitDate': '2010-05-25', 'studyFirstSubmitQcDate': '2007-09-05', 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-07-01', 'studyFirstPostDateStruct': {'date': '2007-09-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Pre- and Post-treatment Reductions of Low-density Lipoprotein Cholesterol (LDL-C) Levels Between the Approved H.E.L.P. System and the Modified H.E.L.P. System.', 'timeFrame': 'Blood samples for LDL-cholesterol determination will be obtained before and after each treatment from week 0 to week 24..'}, {'measure': 'Percent Change of the Pre and Post Treatment Value', 'timeFrame': 'Assessment based on LDL-C values obtained pre-and post-treatment, analyzed from week 0 to week 24.', 'description': 'The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements. Blood samples for LDL-cholesterol determination will be obtained before and after each treatment. The pooled difference between the pre- and post-treatment LDL level for each apheresis machine will be reported as the primary endpoint for the system performance.'}], 'secondaryOutcomes': [{'measure': 'Clinical Lab Profiles (Pre- and Post-Treatment)', 'timeFrame': 'Analyzed at specific time points throughout the study from week 0 to week 24.', 'description': 'Changes in pre- and post-treatment levels of total cholesterol, high-density lipoprotein cholesterol (HDL-C), total triglycerides, lipoprotein (a), fibrinogen, and C-reactive protein.'}, {'measure': 'Device Parameters', 'timeFrame': 'Analyzed at specific time points throughout the study from week 0 to week 24.', 'description': 'Comparison of plasma flow rate recorded with both systems before treatment, after 500 mL of plasma treated, and at the end of each treatment session.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heparin', 'Extracorporeal', 'Low Density Lipo-Protein (LDL) Cholesterol', 'Apheresis', 'Device'], 'conditions': ['Hypercholesterolemia']}, 'referencesModule': {'references': [{'pmid': '12518963', 'type': 'BACKGROUND', 'citation': 'Julius U, Metzler W, Pietzsch J, Fassbender T, Klingel R. Intraindividual comparison of two extracorporeal LDL apheresis methods: lipidfiltration and HELP. Int J Artif Organs. 2002 Dec;25(12):1180-8. doi: 10.1177/039139880202501210.'}, {'pmid': '11778925', 'type': 'BACKGROUND', 'citation': 'Susca M. Heparin-Induced extracorporeal low-density lipoprotein precipitation futura, a new modification of HELP apheresis: technique and first clinical results. Ther Apher. 2001 Oct;5(5):387-93. doi: 10.1046/j.1526-0968.2001.00371.x.'}, {'pmid': '11778924', 'type': 'BACKGROUND', 'citation': 'Schettler V, Monazahian M, Wieland E, Thomssen R, Muller GA. Effect of heparin-induced extracorporeal low-density lipoprotein precipitation (HELP) apheresis on hepatitis C plasma virus load. Ther Apher. 2001 Oct;5(5):384-6. doi: 10.1046/j.1526-0968.2001.00374.x.'}, {'pmid': '11583732', 'type': 'BACKGROUND', 'citation': 'Moriarty PM, Gibson CA, Shih J, Matias MS. C-reactive protein and other markers of inflammation among patients undergoing HELP LDL apheresis. Atherosclerosis. 2001 Oct;158(2):495-8. doi: 10.1016/s0021-9150(01)00633-5.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to demonstrate that the performance of the modified Plasmat® Futura H.E.L.P. Apheresis System is non-inferior to the current FDA approved Plasmat® Secura H.E.L.P Apheresis System for use under the approved indication of the acute reduction of LDL-cholesterol from the plasma in populations for whom diet has been ineffective and maximum drug therapy has either been ineffective or not tolerated.', 'detailedDescription': 'The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements between the approved H.E.L.P. system and the modified H.E.L.P. system. The secondary study endpoints are clinical lab profiles and device parameters analyzed at specific time points throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is between 25 and 70 years of age (inclusive) at the time of randomization.\n* Subject is an appropriate candidate for H.E.L.P. apheresis treatment for hypercholesterolemia according to current Plasmat® Secura approval criteria.\n* Subject has received a minimum of two consecutive bi-monthly\\* H.E.L.P. apheresis treatments using the Plasmat® Secura apheresis system \\>30 days prior to the screening visit.\n* Subject is willing to maintain cholesterol lowering dietary and drug therapies as prescribed through the course of the study.\n* Subject is willing and able to provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) Waiver.\n* Sterile, post-menopausal, or using acceptable birth control for the duration of the study. Acceptable birth control is defined as having a vasectomized, postmenopausal, or sterile partner; the ongoing use of approved hormonal contraceptives, barrier method, or an intrauterine device; or abstinence.\n\n * Every 14 days (±2 days)\n\nExclusion Criteria:\n\n* A History of a known sensitivity to heparin or ethylene oxide.\n* A history of hemorrhagic diathesis, bleeding/clotting disorder, thrombocytopenia (defined as platelet count \\< 150 x109/L), or for whom the use of heparin would cause excessive or uncontrolled anticoagulation or for whom adequate anticoagulation cannot be safely achieved (ie., hemophilia, recent surgery, acute internal bleeding, gastrointestinal ulcers).\n* Females who are pregnant or lactating.\n* Subjects\\< 106 lbs. or \\<48.2 kg in body weight; or whose weight is \\>1.5 times their ideal weight.\n* Certain cardiac impairments such as congestive heart failure, major arrhythmia, or diastolic blood pressure greater than 100 mm/Hg on two separate occasions at least 24 hours apart.\n* Renal insufficiency defined as creatinine greater \\>2.0 mg/dlL or is dependent upon renal dialysis.\n* Untreated hypothyroidism; uncontrolled diabetes mellitus; or fasting triglycerides \\>500 mg/dL.\n* Serious systemic disease (e.g., advanced neoplasms, and acute hepatitis) including Immune system suppression or compromise, that could preclude survival to study completion.\n* History of stroke within 6 months of the screening visit.\n* Received thrombolytic treatment \\< 7 days of screening.visit.\n* Taken or requires a prohibited treatment \\< 30 days prior to the Screening Visit, or requires a prohibited treatment at anytime during the course of the study.\n* Neutropenia (neutrophil count \\< 0.5 x109/L).\n* History of liver disease or serum ALT and/or AST \\> 2X upper limit of normal range.\n* History of dementia.\n* History of anemia (value outside the lower normal range).\n* acetyl salicylic acid (ASA) \\> 325 mg/day.\n* Subject currently enrolled in another investigational study (does not apply to PMS for Secura device).\n* Subject with any other medical condition that in the opinion of the investigator might put the subject at risk or interfere with his/her participation.\n* Subject is unwilling or unable to comply with the protocol or to cooperate fully with the investigator or site personnel.'}, 'identificationModule': {'nctId': 'NCT00526058', 'acronym': 'FUTURA', 'briefTitle': '(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Medical Inc.'}, 'officialTitle': 'Randomized Multicenter Crossover Study to Compare the Plasmat® Futura Heparin Induced Extracorporeal Lower Density Lipo-Protein (LDL) Precipitation (H.E.L.P.) Apheresis System to the Approved Secura System in the Reduction of LDL-c in Patients With Hypercholesterolemia', 'orgStudyIdInfo': {'id': 'LDLc-A-US2-0406'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A (Secura then Futura)', 'description': 'The Group Randomized first to the approved Plasmat® Secura apheresis system and then to the Plasmat® Futura apheresis system.', 'interventionNames': ['Device: Secura then Futura']}, {'type': 'OTHER', 'label': 'B (Futura then Secura)', 'description': 'The Group Randomized first to the approved Plasmat® Futura apheresis system and then to the Plasmat® Secura apheresis system.', 'interventionNames': ['Device: Futura then Secura']}], 'interventions': [{'name': 'Secura then Futura', 'type': 'DEVICE', 'description': 'Randomized to 6 bi-monthly H.E.L.P. therapy treatments with the Plasmat® Secura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Futura apheresis system.', 'armGroupLabels': ['A (Secura then Futura)']}, {'name': 'Futura then Secura', 'type': 'DEVICE', 'description': 'Randomized to 6 bi-monthly H.E L.P. therapy treatments with the Plasmat® Futura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Secura apheresis system.', 'armGroupLabels': ['B (Futura then Secura)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Patrick Moriarty, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}, {'name': 'Paul Thompson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hartford Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Medical Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}