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NCT07147166 · ClinicalTrials.gov registry record · NA
Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy
A NA study of Mastectomy and Gender Dysphoria, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- NA
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT07147166: Recruiting NA study of Mastectomy and Gender Dysphoria, sponsored by University of California, San Francisco.
NCT07147166 is a NA study of Mastectomy and Gender Dysphoria that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 78 participants, below the 123-participant average among 8 other Mastectomy trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07147166, a NA study of Mastectomy and Gender Dysphoria, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- NA
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study Summary
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). Patients will serve as a self-control (one side of the chest receives intervention, the other serves as a control). Primary endpoints include scar appearance and quality. Secondary endpoints include patient perception of the scar using the Patient and Observer Scar Assessment Scale (POSAS). Participants will be taught how to apply Brijjit® at home if any units fall off before 6 weeks postop.
Primary Outcome
Presence or Absence of HTS: HTS defined as a raised, firm fibrotic lesion that develops within the boundaries of surgical incision with a height cutoff of \>/= 1mm. Binary yes or no outcome.
Conditions Studied
Interventions
- DEVICE Brijjit® BP100-6 and BP-75
- OTHER Control: Standard of care and normal wound dressing
Study Locations (1)
California
- UCSF Department of Plastic & Reconstructive Surgery - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2025-02-03 |
| Est. Completion | 2027-06-01 |
| Phase | NA |
What NCT07147166 shows while recruiting
NCT07147166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 123-participant average among 8 other Mastectomy trials with a reported enrollment target (37% lower).
The record links to 3 conditions, with Mastectomy appearing as the primary indexed condition, and to 2 interventions - of which Brijjit® BP100-6 and BP-75 is the first listed.
NCT07147166 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07147166 about?
NCT07147166 is a clinical study titled "Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy". 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,...
What is the current status of trial NCT07147166?
This trial is currently recruiting. It is a NA study. The enrollment target is 78 participants. The study started on 2025-02-03. Estimated completion is 2027-06-01.
What conditions does trial NCT07147166 study?
This clinical trial studies the following conditions: Mastectomy, Gender Dysphoria, Hypertrophic Scar.
What interventions are being tested in trial NCT07147166?
The interventions under investigation include: Brijjit® BP100-6 and BP-75 (DEVICE), Control: Standard of care and normal wound dressing (OTHER).
Who is sponsoring clinical trial NCT07147166?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07147166 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07147166's enrollment target sits among peer trials
78 5th of 8 higher than 4 of 8 other Mastectomy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mastectomy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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