Plexaa For Preconditioning: Gender Affirming Mastectomy

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06502353

Acronym

P4PGAM

Enrollment

Registered

2024-07-16

Start date

2025-08-20

Completion date

2026-06-01

Last updated

2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nipple Graft Loss, Nipple Necrosis

Keywords

Nipple necrosis, Nipple graft loss, Preconditioning

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).

Interventions

DEVICEBLOOM43

Heat preconditioning

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
Compliance	1 day	Proportion of participants who are compliant with the preconditioning protocol
Nipple necrosis/nipple graft loss	30 days	Proportion of participants experiencing partial or complete nipple necrosis/nipple graft loss and the rate of hospital readmission due to this

Countries

United States

Contacts

Primary ContactSaahil Mehta

saahil@plexaa.com447711183551

Backup ContactHadyn Kankam

hadyn@plexaa.com447539351830

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026