Plexaa Device for Gender-Affirming Mastectomy

(P4PGAM Trial)

Overseen By Hadyn Kankam

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Plexaa Ltd

Disqualifiers: Breast cancer, Cardiac pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called Plexaa to evaluate its effectiveness for transgender and non-binary individuals undergoing a gender-affirming mastectomy. The goal is to determine if the device is user-friendly and acceptable for patients. Participants will use the device the night before their surgery. Transgender or non-binary individuals planning a specific type of mastectomy for gender affirmation may be suitable for this study. As an unphased trial, this study allows participants to contribute to research that could enhance surgical experiences for others in the future.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Plexaa device is safe for gender-affirming mastectomy?

Research shows that specific safety information for the Plexaa device used in gender-affirming mastectomy is not yet available. The trial is labeled as "Not Applicable" for its phase, indicating it is in the early stages of testing. This suggests that complete safety data is not yet available.

This does not imply the device is unsafe; rather, more information is needed. Medical professionals closely monitor the Plexaa device in the clinical trial to ensure participant safety and well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Plexaa device because it offers a unique approach to patient preparation for gender-affirming mastectomy surgeries. Unlike traditional methods, which primarily focus on surgical techniques and post-operative care, the Plexaa device is a preconditioning protocol used at home. It involves wearing the BLOOM43 device over the breast in a patient's existing bra the night before surgery. This approach aims to enhance surgical outcomes by conditioning the tissue ahead of time, potentially reducing complications and improving recovery.

What evidence suggests that the Plexaa device is effective for gender-affirming mastectomy?

In this trial, all participants will use the Plexaa device, designed to improve surgery outcomes for gender-affirming mastectomy. In a study with 143 transgender women who had breast implants, the Plexaa device demonstrated a low complication rate of 14.0%, suggesting its safety in surgical preparation. Although specific data on its effectiveness for gender-affirming mastectomy is limited, the device prepares the breast before surgery, potentially reducing complications. This approach relies on the concept that pre-surgery preparation can enhance healing and recovery. ^{2 3 4 5 6}

Who Is on the Research Team?

Dung H Nguyen, MD, PharmD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a transgender or non-binary adult.

I am having surgery for gender affirmation involving my chest.

Exclusion Criteria

I have open or infected wounds on my breast skin.

Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device

I am planning to have breast reconstruction in two stages.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preconditioning

Participants use the Plexaa preconditioning device (BLOOM43) on their right breast the evening before surgery

1 day

1 visit (in-person for surgery)

Surgery

Participants undergo gender affirming mastectomy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, including evaluation of device experience and potential complications

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Plexaa

Trial Overview 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.

How Is the Trial Designed?

Group I: All participants (single arm) Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Plexaa Ltd

Lead Sponsor

Trials

1

Recruited

20+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

A retrospective analysis of the MAUDE database from 2004 to 2014 revealed 9 deaths and 215 injury events linked to electromechanical morcellation, highlighting significant risks associated with this surgical device.

The analysis found that 27 cases involved the morcellation of previously undiagnosed cancers, with 8 of the 9 deaths related to cancer morcellation, indicating a critical safety concern in using these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of Electromechanical Morcellation Reported in the Manufacturer and User Facility Device Experience (MAUDE) Database. Naumann, RW., Brown, J.[2019]

In a study of 143 transgender women who underwent breast augmentation, the complication rate was 14.0%, with no significant differences in complications based on implant placement, size, or shape, indicating a generally safe procedure.

Transgender women tended to receive larger, round implants placed prepectoral more often than cisgender women, yet their complication rates were comparable, suggesting that these differences in implant attributes do not adversely affect surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implant Attributes or Patient Characteristics? Factors Affecting Outcome after Breast Augmentation in Transgender Women. Kamali, A., Sackey, H., Gran, I., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-nipple-necrosis-7-2024-22181

Plexaa Device for Gender-Affirming Mastectomy In a study of 143 transgender women who underwent breast augmentation, the complication rate was 14.0%, with no significant differences in complications based ...

2. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/p/NCT06502353.html

Plexaa For Preconditioning: 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 ...

3. stanfordhealthcare.org stanfordhealthcare.org/trials/p/NCT06502353.html

Plexaa For Preconditioning: Gender Affirming Mastectomy 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 ...

4. ctv.veeva.com ctv.veeva.com/study/plexaa-for-preconditioning-gender-affirming-mastectomy

Plexaa For Preconditioning: Gender Affirming Mastectomy This study aims to understand a participant's experience of the device, including its usability and acceptability. Participants will use the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9555285/

Gender-Affirming Mastectomy Trends and Surgical ... Between 2013-2020, we observed a marked increase in gender-affirming mastectomies in adolescents. The prevalence of surgical complications was low.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06502353

Plexaa For Preconditioning: Gender Affirming Mastectomy 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 ...