Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-28 @ 12:16 AM
Study NCT ID:
NCT02263261
Status:
COMPLETED
Last Update Posted:
2018-09-20
First Post:
2014-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-18', 'studyFirstSubmitDate': '2014-10-06', 'studyFirstSubmitQcDate': '2014-10-10', 'lastUpdatePostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Types and incidence of complications', 'timeFrame': '6 months post reconstruction', 'description': 'Documentaiton of any medical and/or surgical problem requiring treatment that arises as a result of the reconstruction procedure'}], 'secondaryOutcomes': [{'measure': 'Aesthetic Outcomes', 'timeFrame': '6 months post reconstruction', 'description': 'Aesthetic outcomes evaluated by the operating surgeon and two independent board certified plastic surgeons with breast reconstruction expertise'}, {'measure': 'Patient-Reported Outcomes', 'timeFrame': '6 months post reconstruction', 'description': 'Use of the Breast Q survey instrument'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dermal matrix'], 'conditions': ['Mastectomy', 'Breast Reconstruction']}, 'descriptionModule': {'briefSummary': 'Use of a HADM and implant in post-mastectomy breast reconstruction.', 'detailedDescription': 'This is a prospective, single-site pilot study in which outcomes associated with the use of Flex HD® Pliable™ Perforated, Human Acellular Dermal Matrix and an implant which are used in post-mastectomy breast reconstruction will be obtained. The data collected will include reconstructive outcomes, aesthetic outcomes and patient-reported outcomes in order to ascertain advantages and disadvantages of using this particular HADM in post-mastectomy breast reconstruction.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled to undergo a single or two-stage, tissue-assisted, implant breast reconstruction\n* Mastectomy may be unilateral or bilateral, prophylactic or therapeutic\n* Skin incision may be skin sparing, or nipple-areolar sparing\n* Have signed written, informed consent\n* Be at least 18 years of age\n\nExclusion Criteria:\n\n* Patients undergoing autologous breast reconstruction\n* Patients undergoing breast reconstruction following complications of breast augmentation, mastopexy, breast reduction, or breast conservation surgery (lumpectomy)\n* Patients undergoing reconstruction after previously failed attempts at reconstruction\n* Patients undergoing autologous breast reconstruction in conjunction with a tissue expander (such as a latissimus dorsi flap, DIEP flap)\n* There will be no exclusions based on race or ethnicity\n* BMI \\> 40\n* Previous Radiation Treatment. Note: Post-operative radiation treatment does not exclude subjects from study continuation once enrolled.'}, 'identificationModule': {'nctId': 'NCT02263261', 'briefTitle': 'Evaluation of a Human Acellular Dermal Matrix in Post Mastectomy Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Musculoskeletal Transplant Foundation'}, 'officialTitle': 'Reconstructive, Aesthetic and Patient Reported Outcomes Associated With the Use of Flex HD Pliable, Perforated Human Acellular Dermal Matrix in Implant-Based Breast Reconstruction: A Pilot Study', 'orgStudyIdInfo': {'id': 'MTF 13-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Flex HD Pliable Perforated HADM', 'description': 'Single Arm', 'interventionNames': ['Other: Flex HD Pliable Perforated HADM']}], 'interventions': [{'name': 'Flex HD Pliable Perforated HADM', 'type': 'OTHER', 'description': 'Human Acellular Dermal Matrix', 'armGroupLabels': ['Flex HD Pliable Perforated HADM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Liu Plastic surgery', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '95124', 'city': 'San Jose', 'state': 'California', 'country': 'United States', 'facility': 'Liu Plastic Surgery', 'geoPoint': {'lat': 37.33939, 'lon': -121.89496}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Musculoskeletal Transplant Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}