Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-28 @ 4:27 PM
Study NCT ID:
NCT01425268
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2011-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Patient Controlled Tissue Expansion for Breast Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015625', 'term': 'Tissue Expansion Devices'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kkelley@airxpanders.com', 'phone': '650-390-9000', 'title': 'Director of Clinical Affairs', 'phoneExt': '9003', 'organization': 'AirXpanders'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Device improvements occurred during the study with later subjects completing the study with a revised version of the device.\n\nResults include all subjects treated in the study, regardless of device version.'}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'All AEs collected for the safety cohort (all subjects enrolled and procedure started). In the investigational arm (n=98 treated), the safety cohort includes one untreated subject in which the procedure was started but the device was not implanted due to intra-operative findings (positive nodes). Safety cohort for the investigation arm (n=99).\n\nAEs assessed by investigators for severity, seriousness and relationship to device or procedure.\n\nAEs coded to MedDRA standardized terms.', 'eventGroups': [{'id': 'EG000', 'title': 'AeroForm Tissue Expansion', 'description': 'AeroForm Tissue Expansion inflation with carbon dioxide by remote control\n\nAeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 46, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 21}, {'id': 'EG001', 'title': 'Saline Tissue Expansion', 'description': 'Saline Tissue Expansion inflated by needle injections of saline\n\nSaline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 22, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Pain', 'notes': 'Subject Reported Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Delayed Wound Healing', 'notes': 'Delayed Wound Healing / Tissue Necrosis,', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Seroma', 'notes': 'Seroma, Breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Infection', 'notes': 'Post Op Wound Infection / Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'seriousEvents': [{'term': 'Hematoma, Breast', 'notes': 'Post operative hematoma with return to the OR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Stroke, Mild', 'notes': 'Mild Stroke, Admitted Overnight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Neutropenic Fever', 'notes': 'Fever with low wbc associated with chemotherapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Red Breast Syndrome', 'notes': 'Inflammation of the breast tissue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Seroma', 'notes': 'Seroma with needle guided aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Extrusion', 'notes': 'Device extrusion through skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Hematoma, Chest VAP Site', 'notes': 'Hematoma after removal of Venous Access Port', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Cellulitis', 'notes': 'Superficial Cellulitis of Breast', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Wound Infection', 'notes': 'Wound Infection at the Surgical Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Delayed Wound Healing', 'notes': 'Delayed wound healing, tissue necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Wound Dehiscence', 'notes': 'Dehiscence (Separation) of the Incision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Erosion', 'notes': 'Erosion of the skin overlying the expander', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Pneumothorax', 'notes': 'Post operative pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Deflation', 'notes': 'Deflation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Under-Expansion', 'notes': 'Under-Expansion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Over-Expansion', 'notes': 'Over-Expansion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Exposure', 'notes': 'Exposed Tissue Expander', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}, {'term': 'Muscle Disruption', 'notes': 'Disruption of Alloderm-Muscle Interface', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'Breasts', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AeroForm Tissue Expansion', 'description': 'AeroForm Tissue Expansion inflation with carbon dioxide by remote control\n\nAeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.'}, {'id': 'OG001', 'title': 'Saline Tissue Expansion', 'description': 'Saline Tissue Expansion inflated by needle injections of saline\n\nSaline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '149', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'margin of non-inferiority', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '-7.3', 'ciLowerLimit': '-7.3241', 'estimateComment': 'The Treatment Success Rate per breast is 96.1% (149/155) for AeroForm and 98.8% (82/83) for saline.The difference (AeroForm - saline) is -2.7% with a lower confidence limit of -7.3%, meeting the non-inferiority margin of \\> -10%.', 'groupDescription': 'The study was powered to show that the Treatment Success rate for the AeroForm System (πTreatment) was not worse than the rate for the saline expander (πControl) by more than 10% (-0.10 \\< πTreatment - πControl).', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Assuming that the success rate for both expanders was 95%, at least 92 breasts implanted with a AeroForm Tissue Expander and 46 breasts implanted with a saline expander were needed to be 80% confident (i.e., have a statistical power of 80%) that the lower bound of the one-sided 95% Confidence Interval for the difference in the Success rates (πTreatment - πControl) was greater than or equal to -10%.'}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '12 months', 'description': 'The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures.', 'unitOfMeasure': 'Breasts', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Breasts', 'denomUnitsSelected': 'Breasts', 'populationDescription': 'Primary Analysis Population (Per Protocol Cohort) = Subjects with an expander implanted successfully with no major protocol violation (evaluated per breast). Subjects who had a bilateral procedure have each breast evaluated separately.'}, {'type': 'SECONDARY', 'title': 'Expansion Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}, {'units': 'breasts', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AeroForm Tissue Expansion', 'description': 'AeroForm Tissue Expansion inflation with carbon dioxide by remote control\n\nAeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.'}, {'id': 'OG001', 'title': 'Saline Tissue Expansion', 'description': 'Saline Tissue Expansion inflated by needle injections of saline\n\nSaline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '169'}, {'value': '46', 'groupId': 'OG001', 'lowerLimit': '5', 'upperLimit': '280'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Kaplan-Meier Log Rank test', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Subjects not completing tissue expansion are censored in the analysis'}], 'paramType': 'MEDIAN', 'timeFrame': '12 months', 'description': 'The median number of days taken to complete the expansion process.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'breasts', 'denomUnitsSelected': 'breasts', 'populationDescription': 'All breasts successfully exchange from expander to standard breast implant were analyzed for the length of time to complete the expansion process (days)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AeroForm Tissue Expansion', 'description': 'AeroForm Tissue Expansion inflation with carbon dioxide by remote control\n\nAeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.'}, {'id': 'FG001', 'title': 'Saline Tissue Expansion', 'description': 'Saline Tissue Expansion inflated by needle injections of saline\n\nSaline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '106 Subjects Randomized to AeroForm Arm / 98 Subjects Treated (Implanted)', 'groupId': 'FG000', 'numSubjects': '106'}, {'comment': '52 Subjects Randomized to Saline Arm / 52 Subjects Treated (Implanted)', 'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Participants were recruited were current patients at the investigator's practice who were scheduled to undergo two-stage breast reconstruction between November 2011 - December 2014."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AeroForm Tissue Expansion', 'description': 'AeroForm Tissue Expansion inflation with carbon dioxide by remote control\n\nAeroForm Tissue Expansion: The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.'}, {'id': 'BG001', 'title': 'Saline Tissue Expansion', 'description': 'Saline Tissue Expansion inflated by needle injections of saline\n\nSaline Tissue Expansion: A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.'}, {'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': '92', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.9', 'spread': '9.83', 'groupId': 'BG000'}, {'value': '51.1', 'spread': '9.88', 'groupId': 'BG001'}, {'value': '49.7', 'spread': '9.87', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2011-08-26', 'resultsFirstSubmitDate': '2017-02-26', 'studyFirstSubmitQcDate': '2011-08-29', 'lastUpdatePostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-23', 'studyFirstPostDateStruct': {'date': '2011-08-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful Tissue Expansion and Exchange to a Permanent Breast Implant Unless Precluded by a Non-device Related Event', 'timeFrame': '12 months', 'description': 'The primary endpoint is assessed when the subject has completed tissue expansion and completed an exchange to standard breast implants. Subjects not completing the exchange procedure due to a device related event are considered failures.'}], 'secondaryOutcomes': [{'measure': 'Expansion Days', 'timeFrame': '12 months', 'description': 'The median number of days taken to complete the expansion process.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Tissue Expansion', 'Tissue Expander', 'Breast Tissue Expansion', 'Breast Tissue Expander', 'Breast Reconstruction', 'Two Stage Breast Reconstruction', '2 Stage Breast Reconstruction'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '27879582', 'type': 'BACKGROUND', 'citation': 'Ascherman JA, Zeidler K, Morrison KA, Appel JZ, Berkowitz RL, Castle J, Colwell A, Chun Y, Johnson D, Mohebali K. Carbon Dioxide-Based versus Saline Tissue Expansion for Breast Reconstruction: Results of the XPAND Prospective, Randomized Clinical Trial. Plast Reconstr Surg. 2016 Dec;138(6):1161-1170. doi: 10.1097/PRS.0000000000002784.'}, {'pmid': '24740025', 'type': 'DERIVED', 'citation': 'Zeidler KR, Berkowitz RL, Chun YS, Alizadeh K, Castle J, Colwell AS, Desai AR, Evans G, Hollenbeck S, Johnson DJ, Morris D, Ascherman JA. AeroForm patient controlled tissue expansion and saline tissue expansion for breast reconstruction: a randomized controlled trial. Ann Plast Surg. 2014 May;72 Suppl 1:S51-5. doi: 10.1097/SAP.0000000000000175.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to compare the performance and safety of the AirXpander tissue expander to standard saline expanders in patients undergoing two-stage breast reconstruction following mastectomy.', 'detailedDescription': 'This is a pivotal, prospective, multi-center randomized, controlled, open-label clinical study designed to compare the performance and safety of the AirXpander Tissue Expander System to currently cleared saline tissue expanders. Subject who meet the inclusion and agree to participate in the study will be enrolled and randomized to either the investigational arm (AirXpander Tissue Expander) or the control arm (standard saline tissue expander) using a 2:1 (AirXpander to saline) permuted block randomization stratified by investigational center and procedure (unilateral or bilateral). If the subject is having a bilateral procedure, the same type of expander will be implanted in each side. Subjects in both arms will be followed in the same manner until the explantation of the tissue expander(s) and exchange for permanent implant(s).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is a woman between the ages of 18-70.\n2. Subject needs to have tissue expansion as part of her breast reconstruction.\n3. Subject is able to provide written informed consent.\n4. Subject is able and willing to comply with all of the study requirements.\n5. Subject is able to understand and manage at home dosing regimen.\n\nExclusion Criteria:\n\n1. Subjects skin is not suitable for tissue expansion.\n2. Subject has remaining tumor cells following her mastectomy.\n3. Subject has a current or prior infection at the intended expansion site.\n4. Subjects skin has been damaged by previous radiation treatments and the use of non radiated tissue from another part of her body will not be used.\n\n4a. Subject had planned radiation therapy at the intended expansion site while the expander is implanted.\n\n5\\. Subject has a history of failed tissue expansion or breast implantation at the intended expansion site.\n\n6\\. Subject has any existing medical condition that the doctor thinks puts the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes).\n\n7\\. Subject is taking any medications that the doctor thinks puts the subject at an increased risk of complications (e.g., prednisone, Coumadin).\n\n8\\. Subject is currently participating in a concurrent investigational drug or device study.\n\n9\\. Subject is a current tobacco smoker. 10. Subject is overweight (BMI \\> 33). 11. Subject is unwilling to comply with the air travel or altitude restriction of not \\> 3300 feet (1000 meters) from baseline during the time the AeroForm tissue expander is implanted.\n\n12\\. Subject has a currently implanted electronic device such as a pacemaker, defibrillator, neurostimulator device, or drug infusion device.\n\n13\\. Subject is pregnant or planning on becoming pregnant during the study period.\n\n14\\. Subject has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to use the device safely.'}, 'identificationModule': {'nctId': 'NCT01425268', 'acronym': 'XPAND', 'briefTitle': 'Patient Controlled Tissue Expansion for Breast Reconstruction', 'organization': {'class': 'INDUSTRY', 'fullName': 'AirXpanders, Inc.'}, 'officialTitle': 'AirXpanders Patient Activated Controlled Tissue Expander System for Breast Reconstruction', 'orgStudyIdInfo': {'id': 'CTP-0003 AirXpanders'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AeroForm Tissue Expansion', 'description': 'AeroForm Tissue Expansion inflation with carbon dioxide by remote control', 'interventionNames': ['Device: AeroForm Tissue Expansion']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saline Tissue Expansion', 'description': 'Saline Tissue Expansion inflated by needle injections of saline', 'interventionNames': ['Procedure: Saline Tissue Expansion']}], 'interventions': [{'name': 'AeroForm Tissue Expansion', 'type': 'DEVICE', 'otherNames': ['AirXpander Tissue Expander System', 'Patient Activated Controlled Expansion (PACE)', 'AeroForm Patient Activated Tissue Expander', 'AeroForm Tissue Expander System', 'AeroForm Tissue Expander'], 'description': 'The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.', 'armGroupLabels': ['AeroForm Tissue Expansion']}, {'name': 'Saline Tissue Expansion', 'type': 'PROCEDURE', 'otherNames': ['saline breast tissue expander', 'saline expander', 'breast tissue expander', 'tissue expander'], 'description': 'A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.', 'armGroupLabels': ['Saline Tissue Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94904', 'city': 'Greenbrae', 'state': 'California', 'country': 'United States', 'facility': 'Marin General Hospital', 'geoPoint': {'lat': 37.94854, 'lon': -122.5247}}, {'zip': '90004', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Susan Downey', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Healthcare-Sacramento', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95008', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Good Samaritan Hospital, San Jose', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'eSSe Plastic Surgery', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32258', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Medical Center South', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Norton Healthcare Pavilion', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02130', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Faulkner Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '10032-3713', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11572', 'city': 'Oceanside', 'state': 'New York', 'country': 'United States', 'facility': 'South Nassau Communities Hospital', 'geoPoint': {'lat': 40.63871, 'lon': -73.64013}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novant Health Presbyterian Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jeffrey A. Ascherman, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York-Presbyterian Hospital / Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AirXpanders, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}