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Plexaa For Preconditioning: Gender Affirming Mastectomy

A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device (BLOOM43) for Gender Affirming Mastectomy - a Prospective Cohort Study

Who can join

Ages 18 and older · Women

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

About the study

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).

What is being tested

• BLOOM43 (device)

Sponsor: Plexaa Ltd · Participants: 15 · Started: Aug 20, 2025

Contact the study team

• Saahil Mehta · Phone: 447711183551
• Hadyn Kankam · Phone: 447539351830

Official record on ClinicalTrials.gov — NCT06502353

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.