Actively Recruiting
Safety and Effectiveness of FlexHD ae Pliable Acellular Dermal Matrix in Implant-Based Breast Reconstruction
Led by Musculoskeletal Transplant Foundation · Updated on 2025-04-02
259
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Musculoskeletal Transplant Foundation
Lead Sponsor
M
MCRA (an IQVIA business)
Collaborating Sponsor
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 FlexHD ae 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 FlexHD ae 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 22 years or older
- Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction
- Willing to provide informed consent
- Able to attend all required study visits
- Must be able to read and understand English
You will not qualify if you...
- Positive pregnancy test within 7 days of study procedure or of childbearing potential
- Residual gross tumor at the intended reconstruction site
- Previous breast surgery at implantation site except biopsy
- Previous radiation therapy to reconstruction site or chest wall, or planned post-operative radiation therapy
- Completed chemotherapy within 3 weeks prior to surgery
- Comorbid condition increasing risk of complications as determined by investigator
- Body Mass Index (BMI) greater than 35
- Nicotine use within 1 month of screening
- Oral corticosteroid use within 1 month prior to procedure, history of long-term use, or expected use during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to hospital discharge
Participants undergo mastectomy and immediate implant-based, prepectoral breast reconstruction using FlexHD® Pliable.
1 surgical procedure and immediate post-operative care
Duration - 12 months
Participants are monitored for safety, complications, reconstructive outcomes, pain, and adverse events following surgery.
Approximately 6 post-operative visits
Trial Site Locations
Total: 1 location
1
Jonathan Heistein, MD Plastic & Reconstructive Surgery
Fort Worth, Texas, United States, 76092
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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