Status:
NOT_YET_RECRUITING
Evaluating the Effective and Safe Use of Stream™ Platform
Lead Sponsor:
FluidAI Medical
Conditions:
User-Centered Design
Anastomotic Leak
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study aims to demonstrate the potential for at-home monitoring using Stream™ Platform, through simulated-use testing. Lay users, defined as subjects or nonprofessional caregivers, will be asked to...
Eligibility Criteria
Inclusion
- Age ≥ 18 years - male or female.
- Subject/SDM understands and has voluntarily signed and dated Informed Consent Form (ICF).
- Subject underwent colorectal surgery with anastomosis.
- Subjects must be willing to comply with trial requirements.
- Subject has a prophylactic abdominal/pelvic drain after colorectal surgery.
Exclusion
- Subjects/caregiver is unwilling or unable to comply with the requirements of the protocol.
- 24 hours or more have passed since the end of the subject's surgery and consent was not attained.
- The subject had already developed an anastomotic leak at the time of screening and underwent surgery for treatment of the complication.
- Plans that the subject will be discharged in less than 3 days post-surgery.
- Subject has reported that they are pregnant.
- Subject has a permanent end stoma.
- Subject is delirious.
- Subject has severe dementia.
- Subject was involved in the planning and conduct of the clinical investigation.
- Origin™ is not compatible with the drain used on the subject.
- Subject and/or caregiver is/are not capable of conducting the calibrations for Stream™ Platform (this can be self-reported or determined by the CRC/HCP/other research staff).
- The subject and/or caregiver is/are unable to understand the instructions provided for the management and calibration of Stream™ Platform (this can be self-reported or determined by the CRC/investigator/other research staff).
Key Trial Info
Start Date :
March 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06522061
Start Date
March 15 2025
End Date
December 30 2025
Last Update
February 28 2025
Active Locations (1)
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1
St. Paul's Hospital - Providence Healthcare (PHC)
Vancouver, British Columbia, Canada, V6Z 1Y6