Clinical Trial

Plexaa For Preconditioning: Gender Affirming Mastectomy

Study acronym: P4PGAM
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated October 1, 2025 (before its estimated January 1, 2026 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-07-08; most recent amendment 2025-09-25.
Status change: Not Yet Recruiting → Recruiting 2025-09-25
Trial Details
NCT Number NCT06502353
Lead Sponsor Plexaa Ltd
Collaborators: Stanford University
Conditions Nipple Necrosis, Nipple Graft Loss
Enrollment 15 participants
Start Date 2025-08-20
Primary Completion 2026-01-01 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-10-01