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Economic Evaluation of Stream™ Platform | Clinical Trials | Clareo Health

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Economic Evaluation of Stream™ Platform

Economic Evaluation of Stream™ Platform for the Early Detection of Anastomotic Leakage After Gastrointestinal Surgery

NCT05994625•FluidAI Medical

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (2)

Hamilton General Hospital - Hamilton Health Sciences

Hamilton, Ontario, Canada

Juravinski Hospital- Hamilton Health Sciences

Hamilton, Ontrario, Canada

Key Dates

Start Date

December 6, 2023

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2026

Last Updated

March 13, 2025

Enrollment

215

ESTIMATED participants

Conditions

Anastomotic Leak

Interventions

Stream™ Platform

DEVICE

Stream™ Platform with Risk Score Omitted

DEVICE

CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery

NCT07464600

Colorectal SurgeryEnhanced Recovery+3 more

View study

RECRUITING

Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage

NCT06493565

Anastomotic Leak Rectum

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Economic Evaluation of Stream™ Platform

Inclusion Criteria

Exclusion Criteria

CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery

Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage

Anastomotic Leakage in Colorectal Cancer Surgery in Syria

Impact of Arterial Partial Pressure of Oxygen on Anastomotic Leakage After Esophagectomy

The Effect of Perioperative Hyperglycemia on Anastomotic Leaks After Total Gastrectomy

Role of Procalcitonin, C-Reactive Protein, and WBC Count in Prediction of Colorectal Anastomotic Leak