Actively Recruiting
Plexaa For Preconditioning: Gender Affirming Mastectomy
Led by Plexaa Ltd · Updated on 2025-10-01
15
Participants Needed
1
Research Sites
40 weeks
Total Duration
On this page
Sponsors
P
Plexaa Ltd
Lead Sponsor
S
Stanford University
Collaborating Sponsor
AI-Summary
What this Trial 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).
CONDITIONS
Official Title
Plexaa For Preconditioning: Gender Affirming Mastectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Identify as transgender or non-binary
- Be 18 years of age or older
- Undergoing peri-areolar mastectomy or double incision mastectomy with a free nipple graft for gender affirmation
You will not qualify if you...
- Undergoing surgery for breast cancer
- Delayed (two-stage) breast reconstruction
- Undergoing simple mastectomy or wide local excision of a breast tumor
- Having open breast skin wounds or infected/inflamed breast skin
- Having a cardiac pacemaker, defibrillator, or any other implantable electronic device
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Division of Plastic & Reconstructive Surgery, Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
Research Team
S
Saahil Mehta
CONTACT
H
Hadyn Kankam
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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