NCT05994625

Economic Evaluation of Stream™ Platform

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 215 (estimated)
• Sponsor: FluidAI Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anastomotic Leak

Interventions

Type	Name	Description
DEVICE	Stream™ Platform	Stream™ Platform consists of 3 main components: Origin™ , Delta™ Monitor, and Stream™ Application. Origin™ is an inline biosensor system that can be attached inline between an off-the-shelf drainage catheter and reservoir system and is designed to monitor real-time changes in drained effluent characteristics (specifically pH and electrical conductivity (EC)) to identify potential anastomotic leaks. The Stream™ Application is a mobile application for displaying and analyzing data collected continuously via Origin™. Stream™ Application is pre-installed on Android mobile devices (called Delta™ Monitor). Stream™ Platform utilizes the continuous measurements of drain effluent characteristics to generate a Risk Score that is provided to the surgeon. The Risk Score is intended to provide an additional tool for the early diagnosis of anastomotic leakage.
DEVICE	Stream™ Platform with Risk Score Omitted	Stream™ Platform consists of 3 main components: Origin™ , Delta™ Monitor, and Stream™ Application. Origin™ is an inline biosensor system that can be attached inline between an off-the-shelf drainage catheter and reservoir system and is designed to monitor real-time changes in drained effluent characteristics (specifically pH and electrical conductivity (EC)) to identify potential anastomotic leaks. The Stream™ Application is a mobile application for displaying and analyzing data collected continuously via Origin™. Stream™ Application is pre-installed on Android mobile devices (called Delta™ Monitor). This version of Stream™ Platform is utilized purely for observational purposes. Therefore, no Risk Score is generated. This allows postoperative monitoring of patients without any influence from the Stream™ Platform.

Timeline

• Start date: 2023-12-06
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-08-16
• Last updated: 2025-03-13

Locations

2 sites across 1 country: Canada