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Plexaa For Preconditioning: Gender Affirming Mastectomy

Plexaa Ltd · with Stanford University · NCT06502353

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · Women only
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
15
US sites recruiting
1
Study start
August 20, 2025
Record last updated
October 1, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: BLOOM43

Conditions: Nipple Necrosis; Nipple Graft Loss

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Division of Plastic & Reconstructive Surgery, Stanford University

    Palo Alto, CA 94304

    Site contact: Dung Nguyen · 650-498-6004 · nguyendh@stanford.edu

Study contacts (from the official record)

  • Saahil Mehta · 447711183551 · saahil@plexaa.com
  • Hadyn Kankam · 447539351830 · hadyn@plexaa.com
Plexaa For Preconditioning: Gender Affirming Mastectomy (NCT06502353) | Bored Studies