FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction

NCT06797258 | Recruiting DMC FDA Device

• 1 other identifier: MTF 2024-10-IDE
• Study Type: interventional
• Target: 259
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Implant Based Breast Reconstruction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in patient reported outcomes

  12 months

• Pain

  12 months

• Adverse events

  12 months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

FlexHD® Pliable

Device: FlexHD® Pliable; Other: No intervention

Interventions

FlexHD® Pliable DEVICE

Acellular Dermal Matrix

Treatment Arm

No intervention OTHER

Historical Control Arm

Treatment Arm

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Musculoskeletal Transplant Foundation: lead
• MCRA (an IQVIA business): collaborator
• Bruder Consulting International, LLC: collaborator

Study Sites (1)

Jonathan Heistein, MD Plastic & Reconstructive Surgery

Fort Worth, Texas, 76092, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: March 26, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)