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B4P Trial - BLOOM43 for Preconditioning
Sponsor: Plexaa Ltd
Summary
The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in patients undergoing reconstructive breast surgery for breast cancer. 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 breast the evening before undergoing surgery (mastectomy with immediate autologous and/or implant-based reconstruction).
Official title: BLOOM43 for Preconditioning (B4P): A Pilot Study to Evaluate the Use of the Plexaa Preconditioning Device (BLOOM43) for Reconstructive Breast Surgery - A Prospective Cohort Multicentre Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-04-16
Completion Date
2026-12-31
Last Updated
2026-03-19
Healthy Volunteers
No
Interventions
BLOOM43
BLOOM43 works by delivering heat preconditioning to the breast skin before surgery.