Recruiting

Plexaa

Sponsor:

Plexaa Ltd

Code:

NCT06502353

Conditions

Nipple Necrosis

Nipple Graft Loss

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BLOOM43

Study Details

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).

Conditions

Nipple Necrosis

Nipple Graft Loss

Study ID

NCT06502353

Start date

Aug 20, 2025

Status verified date

Sep, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

BLOOM43

Heat preconditioning

Primary outcome measure

  • Participant experience [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Saahil Mehta

447711183551saahil@plexaa.com

Hadyn Kankam

447539351830hadyn@plexaa.com

Locations

Division of Plastic & Reconstructive Surgery, Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Dung Nguyen

650-498-6004nguyendh@stanford.edu

More Information

Sponsor

Plexaa Ltd

Last update posted

Oct 1, 2025

Last verified

Sep, 2025

Keywords

  • Nipple necrosis
  • Nipple graft loss
  • Preconditioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Plexaa Ltd on 2025-10-01.