Not Yet RecruitingNot Applicable

B4P Trial - BLOOM43 for Preconditioning

60 participantsStarted 2026-04-16

Plain-language 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).

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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) Exclusion Criteria: * 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

What they're measuring

Safety of the device

Timeframe: 90 days

Participant experience

Timeframe: 30 days

Trial details

NCT IDNCT07340632

SponsorPlexaa Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-16

Contact for this trial

Saahil Mehta

447711183551 saahil@plexaa.com

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