Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-29 @ 3:54 AM
Study NCT ID:
NCT04060134
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2019-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Breast Reconstruction Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-13', 'studyFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2019-08-15', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Integration Assessment', 'timeFrame': 'From date of surgery through study completion, an average of 9 months', 'description': "Integration assessment for patients with two-stage reconstruction at time of exchange, if available, via surgeon's operative notes"}, {'measure': 'Drain Removal', 'timeFrame': 'From date of surgery through study completion, an average of 9 months', 'description': 'Time to drain removal and volume of fluid drained, if available'}, {'measure': 'Intraoperative fill volume', 'timeFrame': 'From date of surgery through study completion, an average of 9 months', 'description': 'Intraoperative fill volume'}], 'primaryOutcomes': [{'measure': 'Occurrence of Events', 'timeFrame': 'From date of surgery through study completion, an average of 9 months', 'description': 'Occurrence of: infection, hematoma, seroma, capsular contracture, mastectomy skin flap dehiscence, mastectomy skin flap necrosis, expander/implant explantation, red breast syndrome, subsequent surgical interventions related to the breast reconstruction process'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.aziyo.com', 'label': 'Aziyo Biologics, Inc.'}]}, 'descriptionModule': {'briefSummary': 'To collect data on patients who have previously undergone breast reconstruction utilizing SimpliDerm and other HADMs.', 'detailedDescription': 'This study is a retrospective, multi-center, open label study evaluating SimpliDerm and other human acellular dermal matrices in breast reconstruction.\n\nA total of up to 300 patients who underwent direct to implant (one stage) or two-stage unilateral or bilateral breast reconstruction with SimpliDerm an other HADMs at the time of implant or TE placement.\n\nData will be collected for a minimum of one post-surgical visit after direct implant or exchange. If more visits are available, data from those visits will be collected as well.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will consist of up to 300 female patients, who had direct to implant or two-stage immediate breast reconstruction following unilateral or bilateral mastectomy surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patient who underwent immediate breast reconstruction post-mastectomy; either direct to implant or with a tissue expander followed by exchange for a saline or gel implant.\n* HADMs such as: InteguPly, SimpliDerm, AlloDerm, FlexHD, DermACELL, Cortiva, or AlloMax used in the breast reconstruction.\n\nExclusion Criteria:\n\n* Female patient who underwent cosmetic/aesthetic breast augmentation procedure or revision.\n* Female patient who underwent delayed breast reconstruction procedure.\n* Female patient who underwent revision of previous breast reconstruction procedure.'}, 'identificationModule': {'nctId': 'NCT04060134', 'briefTitle': 'A Retrospective Breast Reconstruction Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Elutia Inc.'}, 'officialTitle': 'A Retrospective, Multi-Center, Open Label Study Evaluating SimpliDerm™ and Other Human Acellular Dermal Matrices in Breast Reconstruction', 'orgStudyIdInfo': {'id': 'CLP-0004'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SimpliDerm HADM', 'description': 'Patients who had SimpliDerm human acellular dermal matrix used in their breast reconstruction procedure.', 'interventionNames': ['Other: SimpliDerm HADM']}, {'label': 'AlloDerm HADM', 'description': 'Patients who had AlloDerm human acellular dermal matrix used in their breast reconstruction procedure.', 'interventionNames': ['Other: AlloDerm HADM']}, {'label': 'AlloMax HADM', 'description': 'Patients who had AlloMax human acellular dermal matrix used in their breast reconstruction procedure.', 'interventionNames': ['Other: AlloMax HADM']}, {'label': 'FlexHD HADM', 'description': 'Patients who had FlexHD human acellular dermal matrix used in their breast reconstruction procedure.', 'interventionNames': ['Other: FlexHD HADM']}, {'label': 'DermACELL HADM', 'description': 'Patients who had DermACELL human acellular dermal matrix used in their breast reconstruction procedure.', 'interventionNames': ['Other: DermACELL HADM']}], 'interventions': [{'name': 'SimpliDerm HADM', 'type': 'OTHER', 'description': 'Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.', 'armGroupLabels': ['SimpliDerm HADM']}, {'name': 'AlloDerm HADM', 'type': 'OTHER', 'description': 'Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.', 'armGroupLabels': ['AlloDerm HADM']}, {'name': 'AlloMax HADM', 'type': 'OTHER', 'description': 'Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.', 'armGroupLabels': ['AlloMax HADM']}, {'name': 'FlexHD HADM', 'type': 'OTHER', 'description': 'Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.', 'armGroupLabels': ['FlexHD HADM']}, {'name': 'DermACELL HADM', 'type': 'OTHER', 'description': 'Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.', 'armGroupLabels': ['DermACELL HADM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36116', 'city': 'Montgomery', 'state': 'Alabama', 'country': 'United States', 'facility': 'Baptist Medical Center South', 'geoPoint': {'lat': 32.36681, 'lon': -86.29997}}, {'zip': '35661', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'facility': 'Shoals Plastic Surgery', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tierney Plastic Surgery', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Ascension/Seton Institute of Reconstructive Plastic Surgery', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78504', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'DHR Health', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elutia Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}