Economic Evaluation of Stream™ Platform

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

215

Participants

Timeline

Start Date

December 6, 2023

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Anastomotic Leak
Interventions
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."

Trial Locations (2)

L8L 2X2

Hamilton General Hospital - Hamilton Health Sciences, Hamilton

L8V 1C3

Juravinski Hospital- Hamilton Health Sciences, Hamilton

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Hamilton Health Sciences Corporation

OTHER

collaborator

Ontario Bioscience Innovation Organization

UNKNOWN

lead

FluidAI Medical

INDUSTRY

NCT05994625 - Economic Evaluation of Stream™ Platform | Biotech Hunter | Biotech Hunter