B4P Trial - BLOOM43 for Preconditioning

Starting soon · Not applicable

Conditions studied: Skin Necrosis, Breast Reconstruction, Breast Surgery

In brief

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).

Key facts

Study ID

NCT07340632

Run by

Plexaa Ltd

People needed

60

Starts

2026-04-16

Expected to finish

2026-12-31

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• All females over the age of 18 years (no maximum age limit)
• Patients undergoing skin-sparing mastectomy or nipple-sparing mastectomy and immediate breast reconstruction (autologous and/or implant)

You may not qualify if…

• Delayed (two-stage) breast reconstruction patients
• Patients undergoing simple mastectomy or wide local excision of a breast tumour
• Inflammatory breast cancer patients
• Patients with ulcerated breast tumours
• Patents with T4 breast cancer
• Presence of open breast skin wounds, or infected or inflamed breast skin
• Presence of a cardiac pacemaker, defibrillator or any other implantable electronic device

Full record on ClinicalTrials.gov

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