Plexaa For Preconditioning: Gender Affirming Mastectomy (P4PGAM)

Plexaa Ltd

Status: Enrolling

Conditions: Nipple Necrosis; Nipple Graft Loss

Treatments: Device: BLOOM43

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06502353

75139

Pro00074534 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 15 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

All participants (single arm)

Experimental group

Description:

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.

Treatment:

Device: BLOOM43