Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2026-01-01 @ 9:41 PM
Study NCT ID:
NCT06797258
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2025-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FlexHD® Pliable Investigation in Implant-Based Breast 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': 'ESTIMATED', 'count': 259}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-27', 'studyFirstSubmitDate': '2025-01-22', 'studyFirstSubmitQcDate': '2025-01-22', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of major complication', 'timeFrame': '12 months', 'description': 'Complications that require additional hospitalization or reoperation'}, {'measure': 'Frequency of reconstructive failure', 'timeFrame': '12 months', 'description': 'Removal/explantation of the breast implant'}], 'secondaryOutcomes': [{'measure': 'Change in patient reported outcomes', 'timeFrame': '12 months', 'description': 'Change from baseline in patient reported outcomes as measured by the BREAST-Q (Scoring 0-100; 0=less satisfaction; 100= greater satisfaction)'}, {'measure': 'Pain', 'timeFrame': '12 months', 'description': 'Pain scores as measured by the Numerical Pain Rating Scale (NPRS) (Scoring 0-10; 0=no pain; 10= worst imaginable pain)'}, {'measure': 'Adverse events', 'timeFrame': '12 months', 'description': 'Reported adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Implant Based Breast Reconstruction']}, 'descriptionModule': {'briefSummary': 'Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females at least 22 years of age\n* Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction\n* Willing to provide Informed Consent\n* Able to return for all required study visits\n* Must read and understand English language\n\nExclusion Criteria:\n\n* Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure\n* Has a residual gross tumor at the intended reconstruction site\n* Has undergone previous breast surgery, such as lumpectomy or breast augmentation, at the site of implantation with the exception of a biopsy\n* Has undergone previous radiation therapy to the reconstruction site or chest wall, or is scheduled to undergo post-operative radiation therapy at the reconstruction site\n* Completed chemotherapy within 3 weeks prior to surgery\n* Has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications\n* Has a Body Mass Index (BMI) \\>35\n* Has used nicotine products within 1 month of screening\n* Must not have taken oral corticosteroids for a minimum of 1 month prior to the procedure or have a history of long-term use of systemic oral corticosteroids or anticipate the use during course of the study'}, 'identificationModule': {'nctId': 'NCT06797258', 'acronym': 'SHAPE', 'briefTitle': 'FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Musculoskeletal Transplant Foundation'}, 'officialTitle': 'Safety And Effectiveness Of FlexHD® Pliable Acellular Dermal Matrix In Implant-Based Breast Reconstruction', 'orgStudyIdInfo': {'id': 'MTF 2024-10-IDE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'FlexHD® Pliable', 'interventionNames': ['Device: FlexHD® Pliable', 'Other: No intervention']}], 'interventions': [{'name': 'FlexHD® Pliable', 'type': 'DEVICE', 'description': 'Acellular Dermal Matrix', 'armGroupLabels': ['Treatment Arm']}, {'name': 'No intervention', 'type': 'OTHER', 'description': 'Historical Control Arm', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76092', 'city': 'Fort Worth', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Office', 'role': 'CONTACT', 'phone': '(817) 820-0000'}], 'facility': 'Jonathan Heistein, MD Plastic & Reconstructive Surgery', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Musculoskeletal Transplant Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'MCRA (an IQVIA business)', 'class': 'UNKNOWN'}, {'name': 'Bruder Consulting International, LLC', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}