Actively Recruiting

Phase Not Applicable
Age: 22Years +
FEMALE
NCT06797258

FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction

Led by Musculoskeletal Transplant Foundation · Updated on 2025-04-02

259

Participants Needed

1

Research Sites

122 weeks

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

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

CONDITIONS

Official Title

FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction

Who Can Participate

Age: 22Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 22 years or older
  • Scheduled for unilateral or bilateral mastectomy with immediate implant-based, prepectoral breast reconstruction
  • Willing to provide informed consent
  • Able to attend all required study visits
  • Must read and understand English language
Not Eligible

You will not qualify if you...

  • Positive pregnancy test within 7 days of study procedure if of childbearing potential
  • Presence of residual gross tumor at the reconstruction site
  • Previous breast surgery at the implant site other than biopsy (e.g., lumpectomy, breast augmentation)
  • Previous radiation therapy to the reconstruction site or chest wall, or planned post-operative radiation therapy
  • Chemotherapy completed within 3 weeks before surgery
  • Comorbid conditions increasing risk of complications as determined by investigator
  • Body Mass Index (BMI) greater than 35
  • Nicotine product use within 1 month prior to screening
  • Oral corticosteroid use within 1 month before procedure, history of long-term use, or anticipated use during study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Jonathan Heistein, MD Plastic & Reconstructive Surgery

Fort Worth, Texas, United States, 76092

Actively Recruiting

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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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