NCT06502353

Plexaa For Preconditioning: Gender Affirming Mastectomy

A Pilot Study to Investigate the Use of the Plexaa Preconditioning Device (BLOOM43) for Gender Affirming Mastectomy - a Prospective Cohort Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Plexaa Ltd · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Nipple Necrosis
• Nipple Graft Loss

Interventions

Type	Name	Description
DEVICE	BLOOM43	Heat preconditioning

Timeline

• Start date: 2025-08-20
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2024-07-16
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States