Plexaa Device for Preconditioning in Gender Affirming Mastectomy
Plexaa For Preconditioning: Gender Affirming Mastectomy
Recruiting
N/A
Interventional Study
Nipple Necrosis
Nipple Graft Loss
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 15 (estimated)
- Sponsor
- Plexaa Ltd · Industry
Who this trial is looking for
This trial is looking for transgender and non-binary patients who are 18 or older and are planning to have a gender affirming mastectomy. Participants will use a device to prepare their right breast the night before surgery.
Are You a Good Fit for This Trial?
You may be able to join if
- I am over 18 years old.
- I am transgender or non-binary.
- I am undergoing peri-areolar mastectomy or double incision mastectomy.
You may not be able to join if
- I am having surgery for breast cancer.
- I am having delayed breast reconstruction.
- I am having a simple mastectomy or wide local excision.
- I have open wounds or infected skin on my breast.
- I have a cardiac pacemaker or any other implantable electronic device.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About 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 surge…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* Patients undergoing surgery for breast can…
Contacts