Evaluating the Effective and Safe Use of Stream™ Platform

NANot yet recruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

March 15, 2025

Primary Completion Date

July 30, 2025

Study Completion Date

December 30, 2025

Conditions
User-Centered DesignAnastomotic LeakColorectal SurgeryArtificial Intelligence
Interventions
DEVICE

Stream™ Platform

Stream™ Platform consists of 5 main components: Origin™, Delta™ Monitor, Stream™ Application, Accessory Calibration Syringe(s), and Stream™ Cart. Origin™ is an inline biosensor system that can be attached between an off-the-shelf drainage catheter and evacuator bag/bulb system and is designed to monitor real-time changes in drained effluent characteristics (specifically pH and electrical conductivity (EC)) for the early identification of postoperative complications. Origin™ requires daily calibration (via Accessory Calibration Syringe(s)) for optimal performance and accuracy of its sensors. 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) that are supplied by FluidAI. Origin connects to Stream Application via Bluetooth. Mobile carts/mounts, denoted Stream™ Carts/Delta Mounts, will be used to house the Delta™ Monitor.

Trial Locations (1)

V6Z 1Y6

St. Paul's Hospital - Providence Healthcare (PHC), Vancouver

Sponsors

Lead Sponsor

All Listed Sponsors
lead

FluidAI Medical

INDUSTRY

NCT06522061 - Evaluating the Effective and Safe Use of Stream™ Platform | Biotech Hunter | Biotech Hunter