Plexaa Device for Gender-Affirming Mastectomy

(P4PGAM Trial)

Recruiting in Palo Alto (>99 mi)

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

Trial Summary

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 data supports the effectiveness of the Plexaa treatment for gender-affirming mastectomy?

The research highlights that gender-affirming mastectomy, which includes techniques like the drainless 'masculoplasty', can improve satisfaction with body image and psychosocial function in trans men. Additionally, patient-reported outcome measures (PROMs) specific to gender-affirming care can help align patient goals with realistic expectations, contributing to effective surgical outcomes. ^{1 2 3 4 5}

What safety data exists for the Plexaa Device used in gender-affirming mastectomy?

There is no specific safety data available for the Plexaa Device in the provided research articles. However, general safety information about breast implants, which may be relevant, includes risks associated with silicone gel-filled and saline-filled breast prostheses, as noted by the FDA, and long-term outcomes from breast implant studies. ^{2 6 7 8 9}

How is the Plexaa Device treatment for gender-affirming mastectomy different from other treatments?

The Plexaa Device for gender-affirming mastectomy may offer a unique approach compared to traditional methods by potentially incorporating a drainless technique, which can reduce complications and improve recovery, as suggested by similar drainless techniques used in other gender-affirming surgeries. ^{1 2 10 11 12}

What is the purpose of this trial?

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).

Research Team

Dung H Nguyen, MD, PharmD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Drain-free Technique for Female-to-Male Gender Affirmation Chest Surgery Decreases Morbidity: Outcomes From 306 Consecutive Masculoplasties. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Gender-affirming Mastectomy: Comparison of Periareolar and Double Incision Patterns. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Subcutaneous Mastectomy Improves Satisfaction with Body and Psychosocial Function in Trans Men: Findings of a Cross-Sectional Study Using the BODY-Q Chest Module. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Gender-Affirming Surgery. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Tips and Tricks in Gender-Affirming Mastectomy. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Implant Attributes or Patient Characteristics? Factors Affecting Outcome after Breast Augmentation in Transgender Women. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Silicone gel-filled breast prostheses; silicone inflatable breast prostheses: patient risk information--FDA. Notice. [2004]

9. United States pubmed.ncbi.nlm.nih.gov

US FDA Breast Implant Postapproval Studies: Long-term Outcomes in 99,993 Patients. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Association Between California's State Insurance Gender Nondiscrimination Act and Utilization of Gender-Affirming Surgery. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Gender affirming surgery in non-binary patients: The importance of patient-centered care. [2023]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Does Depth Matter? Factors Affecting Choice of Vulvoplasty Over Vaginoplasty as Gender-Affirming Genital Surgery for Transgender Women. [2019]