FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction (SHAPE)

Safety And Effectiveness Of FlexHD® Pliable Acellular Dermal Matrix In Implant-Based Breast Reconstruction

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

Study Overview

• Status: Recruiting
• Conditions: Implant Based Breast Reconstruction
• Intervention / Treatment: Device: FlexHD® Pliable; Other: No intervention

• Study Type: Interventional
• Enrollment (Estimated): 259
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76092
      • Recruiting
      • Jonathan Heistein, MD Plastic & Reconstructive Surgery
      • Contact: Office; Phone Number: (817) 820-0000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; FlexHD® Pliable	Device: FlexHD® Pliable; Acellular Dermal Matrix; Other: No intervention; Historical Control Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of major complication	Complications that require additional hospitalization or reoperation	12 months
Frequency of reconstructive failure	Removal/explantation of the breast implant	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Musculoskeletal Transplant Foundation
• Collaborators: MCRA (an IQVIA business); Bruder Consulting International, LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: MTF 2024-10-IDE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No