FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction
Recruiting now · Not applicable
Conditions studied: Implant Based Breast Reconstruction
In brief
Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique
Key facts
- Study ID
- NCT06797258
- Run by
- Musculoskeletal Transplant Foundation
- People needed
- 259
- Starts
- 2025-03-26
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2025-04-02
Who can join
Age: 22 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Females at least 22 years of age
- Scheduled to undergo unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction
- Willing to provide Informed Consent
- Able to return for all required study visits
- Must read and understand English language
You may not qualify if…
- Is of childbearing potential and has a positive pregnancy test within 7 days of study procedure
- Has a residual gross tumor at the intended reconstruction site
- Has undergone previous breast surgery, such as lumpectomy or breast augmentation, at the site of implantation with the exception of a biopsy
- 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
- Completed chemotherapy within 3 weeks prior to surgery
- Has been diagnosed with a comorbid condition determined by the investigator to place the subject at an increased risk of complications
- Has a Body Mass Index (BMI) >35
- Has used nicotine products within 1 month of screening
- 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
Where it is running
- Jonathan Heistein, MD Plastic & Reconstructive Surgery — Fort Worth, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.