Plexaa For Preconditioning: Gender Affirming Mastectomy
Part of paid clinical trials in Palo Alto, California.
- Sponsor
- Plexaa Ltd
- Study ID
- NCT06502353
- Status
- Recruiting
Conditions
- Nipple Graft Loss
- Nipple Necrosis
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- BLOOM43 — DEVICEHeat preconditioning
Study Details
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).
Key Dates
- Start date
- Aug 20, 2025
- Status verified
- Sep 2025
- Primary completion
- Jan 1, 2026
- Completion
- Jun 1, 2026
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- PREVENTION
Arms
- 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.
Primary Outcome Measure
Participant experience [ Time Frame: 30 days ]
Central Contacts
- Saahil Mehta447711183551
- Hadyn Kankam447539351830
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Division of Plastic & Reconstructive Surgery, Stanford University | Palo Alto | California | 94304 |