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Economic Evaluation of Stream™ Platform

Anastomotic Leak

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 and up

Participation 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

Study Location

Juravinski Hospital- Hamilton Health Sciences
Juravinski Hospital- Hamilton Health Sciences
Hamilton, Ontrario
Canada

Contact Study Team

Primary Contact

Dr. Pablo E Serrano, MD, MPH, FACS

[email protected]
(905) 521-2100
Hamilton General Hospital - Hamilton Health Sciences
Hamilton General Hospital - Hamilton Health Sciences
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Dr. Edward Passos, MD, FRCSC

[email protected]
905-521-2100
Study Sponsored By
FluidAI Medical
Participants Required
More Information
Study ID: NCT05994625