NCT07340632

Brief 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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

January 5, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

April 16, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 19, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 5, 2026

Last Update Submit

March 17, 2026

Conditions

Skin NecrosisBreast ReconstructionBreast Surgery

Keywords

Mastectomy skin flap necrosisBreast reconstructionBreast surgeryPreconditioningSkin necrosis

Outcome Measures

Primary Outcomes (2)

  • Safety of the device

    Monitoring AEs, ARs, SAEs, SARs, UARs and USARs

    90 days

  • Participant experience

    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

Secondary Outcomes (2)

  • Mastectomy skin flap necrosis

    90 days

  • Compliance

    1 day

Study Arms (1)

All participants (single arm)

EXPERIMENTAL

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

Interventions

BLOOM43DEVICE

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

All participants (single arm)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Jeevan R, Cromwell DA, Browne JP, Caddy CM, Pereira J, Sheppard C, Greenaway K, van der Meulen JH. Findings of a national comparative audit of mastectomy and breast reconstruction surgery in England. J Plast Reconstr Aesthet Surg. 2014 Oct;67(10):1333-44. doi: 10.1016/j.bjps.2014.04.022. Epub 2014 May 14.

    PMID: 24908545BACKGROUND

  • Robertson SA, Jeevaratnam JA, Agrawal A, Cutress RI. Mastectomy skin flap necrosis: challenges and solutions. Breast Cancer (Dove Med Press). 2017 Mar 13;9:141-152. doi: 10.2147/BCTT.S81712. eCollection 2017.

    PMID: 28331365BACKGROUND

  • Mehta S, Rolph R, Cornelius V, Harder Y, Farhadi J. Local heat preconditioning in skin sparing mastectomy: a pilot study. J Plast Reconstr Aesthet Surg. 2013 Dec;66(12):1676-82. doi: 10.1016/j.bjps.2013.07.034. Epub 2013 Sep 4.

    PMID: 24011908BACKGROUND

  • Kankam HKN, Mehta S, Jain A. Thermal Preconditioning for Surgery: A Systematic Review. J Plast Reconstr Aesthet Surg. 2020 Sep;73(9):1645-1664. doi: 10.1016/j.bjps.2020.05.025. Epub 2020 May 21.

    PMID: 32505626BACKGROUND

  • Mehta S, Cro SC, Coomber B, Rolph R, Cornelius V, Farhadi J. A randomised controlled feasibility trial to evaluate local heat preconditioning on wound healing after reconstructive breast surgery: the preHEAT trial. Pilot Feasibility Stud. 2019 Jan 11;5:5. doi: 10.1186/s40814-019-0392-y. eCollection 2019.

    PMID: 30656059BACKGROUND

MeSH Terms

Conditions

Necrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Saahil Mehta

CONTACT

447711183551saahil@plexaa.com

Hadyn Kankam

CONTACT

hadyn@plexaa.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2026

First Posted

January 14, 2026

Study Start

April 16, 2026

Primary Completion (Estimated)

September 16, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 19, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share