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B4P Trial - BLOOM43 for Preconditioning

NCT07340632 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-19

No results posted yet for this study

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).

Conditions

  • Skin Necrosis
  • Breast Reconstruction
  • Breast Surgery

Interventions

DEVICE

BLOOM43

BLOOM43 works by delivering heat preconditioning to the breast skin before surgery.

Sponsors & Collaborators

  • Royal Marsden NHS Foundation Trust

    collaborator OTHER

  • Portsmouth Hospitals NHS Trust

    collaborator OTHER_GOV

  • Plexaa Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-16
Primary Completion
2026-09-16
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07340632 on ClinicalTrials.gov