A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device (BLOOM43) for Gender Affirming Mastectomy - a Prospective Cohort Study
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).
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 d…
Interventions
- DeviceBLOOM43
Heat preconditioning
Location
- Division of Plastic & Reconstructive Surgery, Stanford UniversityPalo Alto, California