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Plexaa For Preconditioning: Gender Affirming Mastectomy

Plexaa For Preconditioning: Gender Affirming Mastectomy

Recruiting
18 years and older
Female
Phase N/A
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Overview

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

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 details
    Nipple Necrosis
    Nipple Graft Loss

NCT06502353

Plexaa Ltd

15 October 2025

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