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
Conditions
Nipple NecrosisNipple Graft Loss
Locations
Division of Plastic & Reconstructive Surgery, Stanford University
Palo Alto, California 94304
United States