Status:
RECRUITING
Plexaa For Preconditioning: Gender Affirming Mastectomy
Lead Sponsor:
Plexaa Ltd
Collaborating Sponsors:
Stanford University
Conditions:
Nipple Necrosis
Nipple Graft Loss
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06502353
Start Date
August 20 2025
End Date
June 1 2026
Last Update
October 1 2025
Active Locations (1)
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1
Division of Plastic & Reconstructive Surgery, Stanford University
Palo Alto, California, United States, 94304