Division of Plastic & Reconstructive Surgery, Stanford University
Palo Alto, California, 94304, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06502353
Plexaa For Preconditioning: Gender Affirming Mastectomy
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).
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
BLOOM43
DeviceHeat preconditioning
Other names: Plexaa preconditioning device
Primary outcomes
-
Participant experience
Time frame: 30 days
Participants' experience of the device will be evaluated with the use of a questionnaire. Most of the questions will consist of multiple-choice components with a five-point scale and there will also be a section for further comments from participants.
Secondary outcomes
-
Compliance
Time frame: 1 day
Proportion of participants who are compliant with the preconditioning protocol
-
Nipple necrosis/nipple graft loss
Time frame: 30 days
Proportion of participants experiencing partial or complete nipple necrosis/nipple graft loss and the rate of hospital readmission due to this
Study contacts
Contact information is provided by the study sponsor or research team.
Hadyn Kankam
CONTACT
Saahil Mehta
CONTACT
Sponsors and collaborators
Lead sponsor
Plexaa Ltd
Industry
Collaborators
- Stanford University
Registry information
Official study title
A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device (BLOOM43) for Gender Affirming Mastectomy - a Prospective Cohort Study
Acronym: P4PGAM
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 16, 2024
- Registry last updated
- Oct 1, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.