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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07147166
The ClinicalTrials.gov registry entry for NCT07147166 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 78 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 123-participant average among 8 other Mastectomy trials with a reported enrollment target (37% lower). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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