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Plexaa For Preconditioning: Gender Affirming Mastectomy
Not Recruiting
Trial ID: NCT06502353
Purpose
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
Stanford Investigator(s)
Dung Nguyen
Clinical Professor, Surgery - Plastic & Reconstructive Surgery
Eligibility
Inclusion Criteria:
* 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
Exclusion Criteria:
* Patients undergoing surgery for breast cancer
* Delayed (two-stage) breast reconstruction patients
* Patients undergoing simple mastectomy or wide local excision of a breast tumour
* Presence of open breast skin wounds, or infected or inflamed breast skin
* Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device
Intervention(s):
device: BLOOM43
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Dung Nguyen
650-498-6004