Left chest with Brijjit® FMTB for Mastectomy

N/A

Waitlist Available

Led By Rachel Bluebond-Langner

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-months post-surgery visit

Awards & highlights

Summary

This trial will test Brijjit® FMTB in patients having double incision gender-affirming mastectomies. The device is used with sutures to improve how scars look and reduce healing issues. One side of the chest will use Brijjit® FMTB, while the other side will use standard care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-months post-surgery visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-months post-surgery visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-months post-surgery visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Colorimetry of Scar

Cicatrization

Subjective scar evaluation by patient outcomes using POSAS

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Right chest with Brijjit® FMTBExperimental Treatment1 Intervention

Patients will be assigned to have their right chest closure completed via Brijjit® FMTB. While the other chest (not selected for intervention) will be closed via traditional suture-based methods and will serve as an internal control.

Group II: Left chest with Brijjit® FMTBExperimental Treatment1 Intervention

Patients will be assigned to have their left chest closure completed via Brijjit® FMTB. While the other chest (not selected for intervention) will be closed via traditional suture-based methods and will serve as an internal control.

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Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,397 Previous Clinical Trials

861,842 Total Patients Enrolled

Rachel Bluebond-LangnerPrincipal InvestigatorNYU Langone Health

~0 spots leftby Sep 2025

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