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All participants (single arm) for Nipple death (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
* 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

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).

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

Timeline

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

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.

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Who is running the clinical trial?

Plexaa LtdLead Sponsor
Stanford UniversityOTHER
2,446 Previous Clinical Trials
17,482,684 Total Patients Enrolled
Dung NguyenPrincipal InvestigatorStanford University
1 Previous Clinical Trials
11 Total Patients Enrolled
~10 spots leftby Mar 2025
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