← Back to Search

Plexaa Device for Gender-Affirming Mastectomy (P4PGAM Trial)

N/A

Waitlist Available

Led By Dung Nguyen

Research Sponsored by Plexaa Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing peri-areolar mastectomy or double incision mastectomy with a free nipple graft for gender affirmation

Be older than 18 years old

Must not have

Delayed (two-stage) breast reconstruction patients

Presence of open breast skin wounds, or infected or inflamed breast skin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the use of the Plexaa preconditioning device (BLOOM43) in transgender and non-binary individuals getting gender affirming mastectomy. Participants will use the device on their

Who is the study for?

This trial is for transgender and non-binary individuals planning to undergo gender affirming mastectomy. It's designed to assess the Plexaa device (BLOOM43) used before surgery. Specific eligibility criteria are not provided, but typically participants must be in good health with no conditions that could interfere with the study.

What is being tested?

The intervention being tested is the Plexaa preconditioning device, BLOOM43. Participants will use this device on their right breast before surgery to see how it affects their experience and recovery from a gender affirming mastectomy.

What are the potential side effects?

Potential side effects are not detailed here, but generally, preconditioning devices may cause discomfort or skin changes at the site of application. The trial aims to gather data on usability and acceptability which includes monitoring for any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having surgery for gender affirmation involving my chest.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am planning to have breast reconstruction in two stages.

Select...

I have open or infected wounds on my breast skin.

Select...

I am having surgery for breast cancer.

Select...

I am having a mastectomy or a surgery to remove a breast tumor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Participant experience

Secondary study objectives

Compliance

Nipple necrosis/nipple graft loss

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: All participants (single arm)Experimental Treatment1 Intervention

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.

0 / 5Eligibility criteria met