FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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

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

FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction

Condition
Implant Based Breast Reconstruction
Intervention / Treatment

-

Contacts and Locations

Fort Worth

Jonathan Heistein, MD Plastic & Reconstructive Surgery, Fort Worth, Texas, United States, 76092

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Musculoskeletal Transplant Foundation,

Study Record Dates

2027-08