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Clinical Trials in the USA / NCT06502353
Recruiting Not applicable

Plexaa For Preconditioning: Gender Affirming Mastectomy

NCT06502353 · tracked via the Priya Life Science USA tracker
Sponsor
Plexaa Ltd
Phase
Not applicable
Started
2025-08-20
Last updated
2025-10-01

Condition(s) studied

Nipple NecrosisNipple Graft Loss

Investigational drug(s) / intervention(s)

BLOOM43

BLOOM43: Heat preconditioning

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
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 device

Primary outcome measure(s)

  • Participant experience — 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.

Trial sites (1)

FacilityCityRegionStatus
Division of Plastic & Reconstructive Surgery, Stanford University Palo Alto California Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06502353 on ClinicalTrials.gov ↗ ← All trials in the USA