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Active Not Recruiting
NCT05994625
Economic Evaluation of Stream™ Platform
Conditions: Anastomotic Leak
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 215
Sponsor: FluidAI Medical
Location: Hamilton General Hospital - Hamilton Health Sciences Hamilton Ontario
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™ Platform for early detection of anastomotic leakage after gastrointestinal surgery. The trial will track patient outcomes and healthcare costs in two groups: the intervention group, where the Stream platform is deployed, and the control group, before the integration of the Stream™ Platform. The data collected from both groups will be compared to assess the impact of implementing the Stream™ Platform and early leak detection on overall patient outcomes and healthcare costs.This trial will include hepatobiliary, colorectal, and trauma/acute care patient populations.
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT05994625). StuddyBuddy aggregates publicly available trial information.