Plexaa For Preconditioning: Gender Affirming Mastectomy (P4PGAM)

September 25, 2025 updated by: Plexaa Ltd

A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device (BLOOM43) for Gender Affirming Mastectomy - a Prospective Cohort Study

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Division of Plastic & Reconstructive Surgery, Stanford University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All participants (single arm)
Each patient will be given the device, BLOOM43, for use at home. It will be worn in a patient's existing bra over their right breast and the preconditioning protocol will be done 12 hours before surgery - i.e. the evening before. Patients will then attend their breast surgery the next day as planned.
Device: BLOOM43
Heat preconditioning
Other Names:
  • Plexaa preconditioning device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days
Compliance
Time Frame: 1 day
Proportion of participants who are compliant with the preconditioning protocol
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Plexaa Ltd

Collaborators

Stanford University

Investigators

  • Principal Investigator: Dung Nguyen, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 26, 2024

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 25, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 75139
  • Pro00074534 (Other Identifier: Advarra)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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