Recruiting NA Gender Dysphoria

Tests treatment safety and results for Gender Dysphoria

Official title Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy

ClinicalTrials.gov ID: NCT07147166

What this study is testing

What it's testing
The goal of this randomized, prospective, interventional clinical trial is to evaluate the use of Brijjit® in reducing the incidence of hypertrophic scarring in individuals undergoing gender-affirming bilateral double incision mastectomies at a single-institution, single-surgeon site (Esther A. Kim, MD).
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 19 and older. Healthy volunteers may be eligible.

You may be able to join if

  • Age ≥ 19
  • Undergoing double incision gender affirming mastectomy
  • Ability to adhere to Brijjit therapy after surgery
  • Willing to return for follow-up visits and undergo study evaluations

You likely can't join if

  • History of keloid formation
  • Radiation therapy history
  • Prior surgeries of the chest or breast
  • History or use following prescription medications: 1) accutane within the past year. 2) chronic systemic steroids
  • Active smoker
  • Disorder known to negatively affect wound healing (autoimmune, connective tissue, uncontrolled diabetes)
See the full eligibility criteria
Who can join
  • Age ≥ 19
  • Undergoing double incision gender affirming mastectomy
  • Ability to adhere to Brijjit therapy after surgery
  • Willing to return for follow-up visits and undergo study evaluations
What rules you out
  • History of keloid formation
  • Radiation therapy history
  • Prior surgeries of the chest or breast
  • History or use following prescription medications: 1) accutane within the past year. 2) chronic systemic steroids
  • Active smoker
  • Disorder known to negatively affect wound healing (autoimmune, connective tissue, uncontrolled diabetes)
  • Any other condition determined by PI to preclude subject from joining study

The study team makes the final eligibility decision.

Where it's taking place

  • San Francisco, California, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 19 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.