Plexaa for Preconditioning: Gender Affirming Mastectomy

Not Applicable

Not yet recruiting

• Conditions: Nipple Graft Loss; Nipple Necrosis
• Interventions: Device: BLOOM43

• Registration Number: NCT06502353
• Lead Sponsor: Plexaa Ltd

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-26
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-08
• Study First Posted: 2024-07-16
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Study Start: 2025-01-01
• Primary Completion: 2025-04-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants (single arm)	BLOOM43	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Division of Plastic & Reconstructive Surgery, Stanford University; 🇺🇸 Palo Alto, California, United States