Clinical Trial

B4P Trial - BLOOM43 for Preconditioning

Not Yet Recruiting
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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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-05.
Trial Details
NCT Number NCT07340632
Lead Sponsor Plexaa Ltd
Collaborators: Royal Marsden NHS Foundation Trust, Portsmouth Hospitals NHS Trust
Conditions Skin Necrosis, Breast Reconstruction, Breast Surgery
Enrollment 60 participants
Start Date 2026-04-16
Primary Completion 2026-09-16 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-19