A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device (BLOOM43) for Gender Affirming Mastectomy - a Prospective Cohort Study
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Division of Plastic & Reconstructive Surgery, Stanford University
RECRUITING
Palo Alto
Contact Information
Primary
Saahil Mehta
saahil@plexaa.com
447711183551
Backup
Hadyn Kankam
hadyn@plexaa.com
447539351830
Time Frame
Start Date: 2025-08-20
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 15
Treatments
Experimental: All participants (single arm)
Each patient will be given the device, BLOOM43, for use at home. It will be worn in a patient's existing bra over their right breast and the preconditioning protocol will be done 12 hours before surgery - i.e. the evening before. Patients will then attend their breast surgery the next day as planned.
Related Therapeutic Areas
Sponsors
Collaborators: Stanford University
Leads: Plexaa Ltd