Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 1:49 AM
Study NCT ID:
NCT07340632
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
B4P Trial - BLOOM43 for Preconditioning
Sponsor:
Plexaa Ltd
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
Participants will use the device to precondition their breast the evening before undergoing surgery (mastectomy with immediate autologous and/or implant-based reconstruction).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NIHR206435 | OTHER | National Institute for Health and Care Research (NIHR) | View |