Actively Recruiting
Study of FlexHD4 Pliable Acellular Dermal Matrix for Implant-Based Breast Reconstruction in Adult Women
Led by Musculoskeletal Transplant Foundation · Updated on 2025-04-02
259
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This clinical study focuses on females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique. It evaluates the safety and effectiveness of FlexHDae Pliable, an acellular dermal matrix device, in this type of breast reconstruction. The study is prospective, multi-center, and single-arm, sponsored by the Musculoskeletal Transplant Foundation. Participants will receive FlexHDae Pliable during their immediate implant-based breast reconstruction after unilateral or bilateral mastectomy. There is no randomization or comparison group in this single-arm study. The intervention involves using the device at the reconstruction site, with no masking or blinding applied. During the 12 months following the procedure, participants will be monitored for major complications and reconstructive failure. Researchers will also assess patient-reported outcomes, pain levels, and any adverse events. Participants must be able to attend all study visits and provide informed consent, with the total study duration covering at least one year post-procedure.
CONDITIONS
Brief Title
FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
