RECRUITING

FlexHD® Pliable Investigation in Implant-Based Breast Reconstruction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-03-26

Study Completion:2027-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06797258

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.

Ages Eligible for Study:22 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

Jonathan Heistein, MD Plastic & Reconstructive Surgery

Fort Worth, Texas, 76092

United States

Collaborators and Investigators

Sponsor: Musculoskeletal Transplant Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-26

Study Completion Date2027-08

Study Record Updates

Study Start Date2025-03-26

Study Completion Date2027-08

Terms related to this study

Additional Relevant MeSH Terms

Implant Based Breast Reconstruction