Could a simple heat device save nipples after top surgery?
NCT ID NCT06502353
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This pilot study tests a heat preconditioning device (BLOOM43) in 15 transgender or non-binary people undergoing gender affirming mastectomy. Participants use the device on their right breast the night before surgery. The study focuses on how usable and acceptable the device is, and also tracks nipple healing and complications.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Plexaa preconditioning device (BLOOM43) - a heat preconditioning device
- What this could lead to
- If successful, this device could reduce the risk of nipple necrosis or graft loss after gender affirming mastectomy, improving surgical outcomes.
- What could go wrong
- This is a very small pilot study with only 15 participants, so results may not apply widely. The device is experimental and its effectiveness is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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Division of Plastic & Reconstructive Surgery, Stanford University
RECRUITINGPalo Alto, California, 94304, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••