B4P Trial - BLOOM43 for Preconditioning
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPlexaa Ltd
About this trial
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).
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- BLOOM43
Treatment groups
60 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Plexaa Ltd
Lead sponsor
Royal Marsden NHS Foundation Trust
Collaborator
Portsmouth Hospitals NHS Trust
Collaborator
Source ClinicalTrials.gov