Plexaa For Preconditioning: Gender Affirming Mastectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPlexaa Ltd
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- BLOOM43
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Plexaa Ltd
Lead sponsor
Stanford University
Collaborator
Source ClinicalTrials.gov