Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-04 @ 12:05 PM
Study NCT ID:
NCT02159118
Status:
COMPLETED
Last Update Posted:
2014-08-25
First Post:
2014-05-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing Use of Manual and Power Bone Marrow Aspiration and Biopsy Devices in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'assanasen@uthscsa.edu', 'phone': '210-567-7456', 'title': 'Chatchawin Assanasen, MD', 'organization': 'The University of Texas Health Science Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Participants will be assessed for adverse events for the duration of the bone marrow sampling procedure, an average of 4 hours.', 'description': "Adverse events reported to the investigators subsequent to a participant's participation will be investigated.", 'eventGroups': [{'id': 'EG000', 'title': 'Manual Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Manual bone marrow aspiration and biopsy device\n\nManual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Powered Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Powered bone marrow aspiration and biopsy device\n\nPowered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.', 'otherNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Manual Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Manual bone marrow aspiration and biopsy device\n\nManual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}, {'id': 'OG001', 'title': 'Powered Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Powered bone marrow aspiration and biopsy device\n\nPowered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.5', 'spread': '21.8', 'groupId': 'OG000'}, {'value': '55.8', 'spread': '19.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'within 24 hours of bone marrow sampling procedure', 'description': 'Bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for percent of hematopoietic tissue present. Higher percentage of hematopoietic tissue present in a biopsy specimen indicates a larger quantity of specimen for pathological evaluation.', 'unitOfMeasure': '% Hematopoetic tissue present', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in analysis, as the required sample size for the study was met. No subjects were excluded from analysis. Analysis was made per protocol.'}, {'type': 'SECONDARY', 'title': 'Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Manual Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Manual bone marrow aspiration and biopsy device\n\nManual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}, {'id': 'OG001', 'title': 'Powered Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Powered bone marrow aspiration and biopsy device\n\nPowered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.9', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '4.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'within 24 hours of the bone marrow sampling procedure', 'description': 'bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for length.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.'}, {'type': 'SECONDARY', 'title': 'Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Manual Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Manual bone marrow aspiration and biopsy device\n\nManual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}, {'id': 'OG001', 'title': 'Powered Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Powered bone marrow aspiration and biopsy device\n\nPowered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'within 24 hours of the bone marrow sampling procedure', 'description': 'bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for width.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.'}, {'type': 'SECONDARY', 'title': 'Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Manual Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Manual bone marrow aspiration and biopsy device\n\nManual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}, {'id': 'OG001', 'title': 'Powered Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Powered bone marrow aspiration and biopsy device\n\nPowered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.8', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '36.5', 'spread': '16.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'within 24 hours of the bone marrow sampling procedure', 'description': 'bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for volume', 'unitOfMeasure': 'mm3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.'}, {'type': 'SECONDARY', 'title': 'Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'units': 'needle passes', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Manual Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Manual bone marrow aspiration and biopsy device\n\nManual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}, {'id': 'OG001', 'title': 'Powered Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Powered bone marrow aspiration and biopsy device\n\nPowered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'at time of the bone marrow sampling procedure', 'description': 'number of needle passes required to capture one bone marrow biopsy specimen using the manual device and the powered device', 'unitOfMeasure': 'needle passes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'needle passes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'All participants enrolled in the study were included in the analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.'}, {'type': 'SECONDARY', 'title': 'Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Manual Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Manual bone marrow aspiration and biopsy device\n\nManual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}, {'id': 'OG001', 'title': 'Powered Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Powered bone marrow aspiration and biopsy device\n\nPowered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '34.1', 'groupId': 'OG000'}, {'value': '53.2', 'spread': '30.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.93', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'at time of the bone marrow sampling procedure', 'description': 'measurement of the amount of time required to acquire a bone marrow aspiration specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the aspiration specimen has been collected.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.'}, {'type': 'SECONDARY', 'title': 'Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Manual Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Manual bone marrow aspiration and biopsy device\n\nManual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}, {'id': 'OG001', 'title': 'Powered Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Powered bone marrow aspiration and biopsy device\n\nPowered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'spread': '0.94', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '1.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'within 4 hours of the bone marrow sampling procedure', 'description': 'Within 4 hours of the bone marrow sampling procedure, the patient will report their level of pain post-procedure using the Wong-Baker FACES pain rating scale. The scale measures pain from 0-10, where higher numbers represent worse pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.'}, {'type': 'SECONDARY', 'title': 'Operator Satisfaction With Manual Device and Powered Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Manual Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Manual bone marrow aspiration and biopsy device\n\nManual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}, {'id': 'OG001', 'title': 'Powered Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Powered bone marrow aspiration and biopsy device\n\nPowered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.51', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Within 24 hours of the bone marrow sampling procedure', 'description': 'Device operators will report their level of satisfaction with use of the manual device and the powered device to perform the bone marrow sampling procedure. Level of satisfaction is reported using a 0 to 10 scale, where higher numbers represent a higher level of satisfaction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis as the requires sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.'}, {'type': 'SECONDARY', 'title': 'Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Manual Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Manual bone marrow aspiration and biopsy device\n\nManual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}, {'id': 'OG001', 'title': 'Powered Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Powered bone marrow aspiration and biopsy device\n\nPowered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}], 'classes': [{'categories': [{'measurements': [{'value': '252.4', 'spread': '95.4', 'groupId': 'OG000'}, {'value': '224.5', 'spread': '143.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'at time of the bone marrow sampling procedure', 'description': 'measurement of the amount of time required to acquire one bone marrow biopsy specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the biopsy specimen has been collected.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants enrolled in the study were included in the analysis as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Manual Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Manual bone marrow aspiration and biopsy device\n\nManual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}, {'id': 'FG001', 'title': 'Powered Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Powered bone marrow aspiration and biopsy device\n\nPowered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Manual Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Manual bone marrow aspiration and biopsy device\n\nManual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}, {'id': 'BG001', 'title': 'Powered Bone Marrow Aspiration and Biopsy Procedure', 'description': 'Powered bone marrow aspiration and biopsy device\n\nPowered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '9.7', 'spread': '4.8', 'groupId': 'BG001'}, {'value': '9.84', 'spread': '5.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants enrolled in the study were included in the baseline analysis, as the required sample size for the study was met. No participants were excluded from analysis. Analysis was made per protocol.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-08', 'studyFirstSubmitDate': '2014-05-15', 'resultsFirstSubmitDate': '2014-07-15', 'studyFirstSubmitQcDate': '2014-06-05', 'lastUpdatePostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-08-08', 'studyFirstPostDateStruct': {'date': '2014-06-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Hematopoietic Tissue Present in Bone Marrow Biopsy Specimens Obtained Using the Manual Device and Powered Device', 'timeFrame': 'within 24 hours of bone marrow sampling procedure', 'description': 'Bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for percent of hematopoietic tissue present. Higher percentage of hematopoietic tissue present in a biopsy specimen indicates a larger quantity of specimen for pathological evaluation.'}], 'secondaryOutcomes': [{'measure': 'Bone Marrow Biopsy Specimen Size (Length) Obtained Using the Manual Device and the Powered Device', 'timeFrame': 'within 24 hours of the bone marrow sampling procedure', 'description': 'bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for length.'}, {'measure': 'Bone Marrow Biopsy Specimen Size (Width) Obtained Using the Manual Device and the Powered Device', 'timeFrame': 'within 24 hours of the bone marrow sampling procedure', 'description': 'bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for width.'}, {'measure': 'Bone Marrow Biopsy Specimen Size (Volume) Obtained Using the Manual Device and the Powered Device', 'timeFrame': 'within 24 hours of the bone marrow sampling procedure', 'description': 'bone marrow biopsy specimens will be evaluated by a blinded pathologist and measured for volume'}, {'measure': 'Bone Marrow Biopsy Specimen Capture Rate for the Manual Device and the Powered Device', 'timeFrame': 'at time of the bone marrow sampling procedure', 'description': 'number of needle passes required to capture one bone marrow biopsy specimen using the manual device and the powered device'}, {'measure': 'Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Aspiration Specimen Acquisition Using the Manual Device and the Powered Device', 'timeFrame': 'at time of the bone marrow sampling procedure', 'description': 'measurement of the amount of time required to acquire a bone marrow aspiration specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the aspiration specimen has been collected.'}, {'measure': 'Patient Level of Post-procedural Pain Following Use of the Manual Device and the Powered Device', 'timeFrame': 'within 4 hours of the bone marrow sampling procedure', 'description': 'Within 4 hours of the bone marrow sampling procedure, the patient will report their level of pain post-procedure using the Wong-Baker FACES pain rating scale. The scale measures pain from 0-10, where higher numbers represent worse pain.'}, {'measure': 'Operator Satisfaction With Manual Device and Powered Device', 'timeFrame': 'Within 24 hours of the bone marrow sampling procedure', 'description': 'Device operators will report their level of satisfaction with use of the manual device and the powered device to perform the bone marrow sampling procedure. Level of satisfaction is reported using a 0 to 10 scale, where higher numbers represent a higher level of satisfaction.'}, {'measure': 'Amount of Time Lapsed From Needle to Skin Contact to Bone Marrow Biopsy Specimen Acquisition Using the Manual Device and the Powered Device', 'timeFrame': 'at time of the bone marrow sampling procedure', 'description': 'measurement of the amount of time required to acquire one bone marrow biopsy specimen. timing starts when the bone marrow aspiration and biopsy needle first contacts the skin and ends when the biopsy specimen has been collected.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bone marrow aspiration', 'bone marrow biopsy', 'OnControl', 'powered bone marrow aspiration and biopsy device', 'standard manual bone marrow aspiration and biopsy device'], 'conditions': ['Bone Marrow Aspiration and Biopsy Specimen Collection']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare use of a powered bone marrow aspiration and biopsy device (OnControl) to use of a standard manual bone marrow aspiration and biopsy device to obtain bone marrow biopsy specimens in children. The hypothesis is that use of the powered device will improve the quantity and quality of bone marrow biopsy specimens when compared to the manual device.', 'detailedDescription': 'The purpose of this randomized, prospective trial is to compare use of the standard manual bone marrow aspiration and biopsy device to use of the powered bone marrow aspiration and biopsy device (OnControl) to obtain bone marrow biopsy specimens in pediatric patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent and assent for minors over the age of seven years must be obtained before any trial-related activities are initiated\n* Patients requiring bone marrow aspirations and/or biopsies as part of standard diagnosis and treatment\n* Treated at Christus Santa Rosa Children's hospital\n* Age 2 to 18 years\n* Male or female\n* Supportive family with willingness to participate in completing questionnaires\n* English or Spanish primary language\n\nExclusion Criteria:\n\n* Patients who are pregnant\n* Patients with hemorrhagic disorders such as congenital coagulation factor deficiencies disseminated intravascular coagulation and concomitant use of anticoagulants\n* Patients with a skin infection or recent radiation therapy at the sampling site\n* Patients with bone disorders such as osteomyelitis or osteogenesis imperfecta"}, 'identificationModule': {'nctId': 'NCT02159118', 'briefTitle': 'A Study Comparing Use of Manual and Power Bone Marrow Aspiration and Biopsy Devices in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vidacare Corporation'}, 'officialTitle': 'A Trial of the Vidacare Powered Bone Marrow Aspiration and Core Biopsy System (OnControl by Vidacare) Compared to Traditional Manual Devices in Children', 'orgStudyIdInfo': {'id': '2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Manual bone marrow aspiration and biopsy procedure', 'description': 'Manual bone marrow aspiration and biopsy device', 'interventionNames': ['Device: Manual bone marrow aspiration and biopsy device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Powered bone marrow aspiration and biopsy procedure', 'description': 'Powered bone marrow aspiration and biopsy device', 'interventionNames': ['Device: Powered bone marrow aspiration and biopsy device']}], 'interventions': [{'name': 'Manual bone marrow aspiration and biopsy device', 'type': 'DEVICE', 'description': 'Use of the manual bone marrow aspiration and biopsy device to collect bone marrow aspiration and bone marrow biopsy specimens.', 'armGroupLabels': ['Manual bone marrow aspiration and biopsy procedure']}, {'name': 'Powered bone marrow aspiration and biopsy device', 'type': 'DEVICE', 'otherNames': ['OnControl'], 'description': 'Use of the powered bone marrow aspiration and biopsy device to collect bone marrow aspiration specimens and bone marrow biopsy specimens.', 'armGroupLabels': ['Powered bone marrow aspiration and biopsy procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78207', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': "Christus Santa Rosa Children's Hospital", 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Chatchawin Assanasen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Christus Santa Rosa Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vidacare Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Pediatric Hematology/Oncology', 'investigatorFullName': 'Chatchawin Assanasen, MD', 'investigatorAffiliation': 'The University of Texas Health Science Center at San Antonio'}}}}