Using the Plexaa BLOOM43 device before gender-affirming mastectomy
A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device (BLOOM43) for Gender Affirming Mastectomy - a Prospective Cohort Study
This will test whether using the Plexaa BLOOM43 device the night before a gender-affirming mastectomy is easy to use and acceptable for transgender and non-binary adults and could lower the chance of nipple necrosis or nipple graft loss.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Plexaa Ltd Industry-sponsored |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT06502353 on ClinicalTrials.gov |
What this trial studies
This single-arm interventional protocol asks transgender and non-binary adults having peri-areolar or double-incision mastectomy with free nipple grafts to apply the Plexaa BLOOM43 device to their right breast the evening before surgery. The study collects participant-reported experience measures focused on device usability, comfort, and acceptability as well as clinical outcomes related to nipple necrosis and graft loss. Patients with open or infected breast skin, those having cancer-related or delayed reconstruction, or those with implantable electronic devices are excluded. The trial is run in collaboration with Stanford University's Division of Plastic & Reconstructive Surgery at the Palo Alto site.
Who should consider this trial
Good fit: Ideal candidates are transgender or non-binary adults (18+) undergoing peri-areolar or double-incision mastectomy with a free nipple graft for gender affirmation who do not have open or infected breast skin and do not have implantable electronic devices.
Not a fit: Patients having surgery for breast cancer, delayed two-stage reconstruction, simple mastectomy or wide local excision, those with open or infected breast skin, or anyone with a pacemaker/defibrillator or other implantable electronic device are not eligible and are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, preconditioning with the Plexaa device could reduce rates of nipple necrosis and nipple graft loss after gender-affirming mastectomy and improve surgical outcomes.
How similar studies have performed: Some prior surgical and graft-preconditioning research suggests preconditioning can reduce tissue necrosis, but use of the Plexaa BLOOM43 in this specific population is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Palo Alto, California
- Division of Plastic & Reconstructive Surgery, Stanford University — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Dung Nguyen — Stanford University
- Study coordinator: Saahil Mehta
- Email: saahil@plexaa.com
- Phone: 447711183551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.