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Plexaa For Preconditioning: Gender Affirming Mastectomy
Sponsor: Plexaa Ltd
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).
Official title: A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device (BLOOM43) for Gender Affirming Mastectomy - a Prospective Cohort Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2025-08-20
Completion Date
2026-06-01
Last Updated
2025-10-01
Healthy Volunteers
No
Conditions
Interventions
BLOOM43
Heat preconditioning
Locations (1)
Division of Plastic & Reconstructive Surgery, Stanford University
Palo Alto, California, United States