FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction

Not Applicable

Recruiting

• Conditions: Implant Based Breast Reconstruction

• Registration Number: NCT06797258
• Lead Sponsor: Musculoskeletal Transplant Foundation

Brief Summary

Prospective, multi-center, single-arm clinical study in females undergoing immediate implant-based breast reconstruction using a pre-pectoral technique

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Study Start: 2025-03-26
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 259

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency of major complication	12 months	Complications that require additional hospitalization or reoperation
Frequency of reconstructive failure	12 months	Removal/explantation of the breast implant

Secondary Outcome Measures

Name	Time	Method
Adverse events	12 months	Reported adverse events
Change in patient reported outcomes	12 months	Change from baseline in patient reported outcomes as measured by the BREAST-Q (Scoring 0-100; 0=less satisfaction; 100= greater satisfaction)
Pain	12 months	Pain scores as measured by the Numerical Pain Rating Scale (NPRS) (Scoring 0-10; 0=no pain; 10= worst imaginable pain)

Trial Locations

Locations (1)

Jonathan Heistein, MD Plastic & Reconstructive Surgery; 🇺🇸 Fort Worth, Texas, United States