Back to Trials
NCT06502353NARecruiting

Plexaa For Preconditioning: Gender Affirming Mastectomy

Plexaa Ltd

Start Date

8/20/2025

Completion Date

6/1/2026

Summary

The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in transgender and non-binary patients undergoing gender affirming mastectomy. This study aims to understand a participant's experience of the device, including its usability and acceptability. Participants will use the device to precondition their right breast the evening before undergoing surgery (gender affirming mastectomy).

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * All transgender or non-binary patients over the age of 18 years (no maximum age limit) * Patients undergoing peri-areolar mastectomy or double incision mastectomy with a free nipple graft for gender affirmation Exclusion Criteria: * Patients undergoing surgery for breast cancer * Delayed (two-stage) breast reconstruction patients * Patients undergoing simple mastectomy or wide local excision of a breast tumour * Presence of open breast skin wounds, or infected or inflamed breast skin * Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device

Interventions

DEVICE

BLOOM43

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Nipple NecrosisNipple Graft Loss

Locations

Division of Plastic & Reconstructive Surgery, Stanford University

Palo Alto, California 94304

United States