B4P Trial - BLOOM43 for Preconditioning

March 17, 2026 updated by: Plexaa Ltd

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All participants (single arm)
Each patient will be given the device, BLOOM43, for use at home. It will be worn in a patient's existing bra over their ipsilateral breast (the breast to be operated on) and the preconditioning protocol will be undertaken 12 hours before surgery - i.e. the evening before. Patients will then attend hospital for their breast surgery the next day as planned. For the patients undergoing bilateral skin/nipple-sparing mastectomy with immediate reconstruction, they will be asked to precondition only the right breast.
Device: BLOOM43
BLOOM43 works by delivering heat preconditioning to the breast skin before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant experience
Time Frame: 30 days
Participants' experience of the device will be evaluated with the use of a questionnaire. Most of the questions will consist of multiple-choice components with a five-point scale and there will also be a section for further comments from participants.
30 days
Safety of the device
Time Frame: 90 days
Monitoring AEs, ARs, SAEs, SARs, UARs and USARs
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance
Time Frame: 1 day
Proportion of participants who are compliant with the preconditioning protocol
1 day
Mastectomy skin flap necrosis
Time Frame: 90 days
Proportion of participants experiencing mastectomy skin flap necrosis and the rates of hospital re-admission and surgical re-intervention due to this
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Plexaa Ltd

Collaborators

Royal Marsden NHS Foundation Trust
Portsmouth Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 16, 2026

Primary Completion (Estimated)

September 16, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B4PTrial
  • NIHR206435 (Other Identifier: National Institute for Health and Care Research (NIHR))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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