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B4P Trial - BLOOM43 for Preconditioning | Clinical Trials | Clareo Health

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Not Yet RecruitingNANCT07340632

B4P Trial - BLOOM43 for Preconditioning

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 underst...

Lead sponsor: Plexaa Ltd•View source on ClinicalTrials.gov

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Contacts

Saahil Mehta

CONTACT

447711183551 saahil@plexaa.com

Hadyn Kankam

CONTACT

hadyn@plexaa.com

Sponsors

Lead Sponsor

Plexaa Ltd

Collaborators

Royal Marsden NHS Foundation Trust
Portsmouth Hospitals NHS Trust

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 19, 2026Terms

Trial snapshot

StatusNOT_YET_RECRUITING

PhaseNA

Enrollment60

Start dateApr 2026

Last updatedMar 19, 2026

Condition

Skin Necrosis Breast Reconstruction Breast Surgery

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: April 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions