Status:
ACTIVE_NOT_RECRUITING
Economic Evaluation of Stream™ Platform
Lead Sponsor:
FluidAI Medical
Collaborating Sponsors:
Hamilton Health Sciences Corporation
Ontario Bioscience Innovation Organization
Conditions:
Anastomotic Leak
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This Economic Evaluation study is a multi-center, two-arm, non-randomized, interventional trial. The purpose of this study is to evaluate the economic and patient outcomes of using the Stream™ Platfor...
Eligibility Criteria
Inclusion
- Age ≥ 18 years - Male or Female
- Subject understands and has voluntarily signed and dated the informed consent form (ICF).
- Subjects must be willing to comply with trial requirements
- Subject has performed an open or laparoscopic surgery with peritoneal or pelvic drainage
Exclusion
- Subject is pregnant
- Subject will be discharged \< 8 hours post-surgery
- 24 or more have passed since the end of the subject's surgery
- Involvement in the planning and conduct of the clinical investigation
- Subject is allergic to contrast medium
- Participation in another investigational drug or device study which would interfere with the endpoints of this study
- Device does not attach to drain used on the subject
Key Trial Info
Start Date :
December 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT05994625
Start Date
December 6 2023
End Date
June 1 2026
Last Update
March 13 2025
Active Locations (2)
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1
Hamilton General Hospital - Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
2
Juravinski Hospital- Hamilton Health Sciences
Hamilton, Ontrario, Canada, L8V 1C3