Plexaa For Preconditioning: Gender Affirming Mastectomy

Recruiting now · Not applicable

Conditions studied: Nipple Necrosis, Nipple Graft Loss

In brief

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).

Key facts

Study ID

NCT06502353

Run by

Plexaa Ltd

People needed

15

Starts

2025-08-20

Expected to finish

2026-06-01

Last updated by the study team

2025-10-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Division of Plastic & Reconstructive Surgery, Stanford University — Palo Alto, California, United States (enrolling)

Full record on ClinicalTrials.gov

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