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NCT06502353 · ClinicalTrials.gov registry record · NA
Plexaa For Preconditioning: Gender Affirming Mastectomy
A NA study of Nipple Necrosis and Nipple Graft Loss, sponsored by Plexaa.
- Recruiting
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT06502353: Recruiting NA study of Nipple Necrosis and Nipple Graft Loss, sponsored by Plexaa.
NCT06502353 is a NA study of Nipple Necrosis and Nipple Graft Loss that is actively recruiting participants, run by Plexaa. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06502353, a NA study of Nipple Necrosis and Nipple Graft Loss, is actively recruiting participants, sponsored by Plexaa.
- RECRUITING
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE BLOOM43
Study Locations (1)
California
- Division of Plastic & Reconstructive Surgery, Stanford University - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-08-20 |
| Est. Completion | 2026-06-01 |
| Phase | NA |
What NCT06502353 shows while recruiting
NCT06502353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Nipple Necrosis appearing as the primary indexed condition, and to 1 intervention - of which BLOOM43 is the first listed.
NCT06502353 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06502353 about?
NCT06502353 is a clinical study titled "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 affirming mastectomy. This study aims to understand a participant's experience of the device, including its usability and acceptability. Par...
What is the current status of trial NCT06502353?
This trial is currently recruiting. It is a NA study. The enrollment target is 15 participants. The study started on 2025-08-20. Estimated completion is 2026-06-01.
What conditions does trial NCT06502353 study?
This clinical trial studies the following conditions: Nipple Necrosis, Nipple Graft Loss.
What interventions are being tested in trial NCT06502353?
The interventions under investigation include: BLOOM43 (DEVICE).
Who is sponsoring clinical trial NCT06502353?
This trial is sponsored by Plexaa, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06502353 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06502353's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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