Trials / Not Yet Recruiting
Not Yet RecruitingNCT07340632
B4P Trial - BLOOM43 for Preconditioning
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Plexaa Ltd · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BLOOM43 | BLOOM43 works by delivering heat preconditioning to the breast skin before surgery. |
Timeline
- Start date
- 2026-04-16
- Primary completion
- 2026-09-16
- Completion
- 2026-12-31
- First posted
- 2026-01-14
- Last updated
- 2026-03-19
Source: ClinicalTrials.gov record NCT07340632. Inclusion in this directory is not an endorsement.