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RECRUITING
NCT06502353
NA

Plexaa For Preconditioning: Gender Affirming Mastectomy

Sponsor: Plexaa Ltd

View on ClinicalTrials.gov

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).

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2025-08-20

Completion Date

2026-06-01

Last Updated

2025-10-01

Healthy Volunteers

No

Interventions

DEVICE

BLOOM43

Heat preconditioning

Locations (1)

Division of Plastic & Reconstructive Surgery, Stanford University

Palo Alto, California, United States