NCT06502353 Plexaa For Preconditioning: Gender Affirming Mastectomy
| NCT ID | NCT06502353 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Plexaa Ltd |
| Condition | Nipple Necrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-08-20 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2025-08-20 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Dung Nguyen
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT06502353 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Nipple Necrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06502353 currently recruiting?
Yes, NCT06502353 is actively recruiting participants. Contact the research team at saahil@plexaa.com for enrollment information.
Where is the NCT06502353 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT06502353 clinical trial?
NCT06502353 is sponsored by Plexaa Ltd. The principal investigator is Dung Nguyen at Stanford University. The trial plans to enroll 15 participants.