NCT06522061

Evaluating the Effective and Safe Use of Stream™ Platform

Evaluating the Effective and Safe Use of Stream™ Platform by a Lay User in a Simulated Environment

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: FluidAI Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study aims to demonstrate the potential for at-home monitoring using Stream™ Platform, through simulated-use testing. Lay users, defined as subjects or nonprofessional caregivers, will be asked to operate Stream™ Platform. Safety, efficacy, and usability data will be collected to ensure that users are able to comply with prescribed device use. Additionally, clinical testing will be conducted to identify correlations between measurements from Stream™ Platform and standard laboratory, radiological, and clinical assessments used for leak detection as part of the current standard of care (SOC) that may be skipped if the subject is discharged early.

Conditions

• User-Centered Design
• Anastomotic Leak
• Colorectal Surgery
• Artificial Intelligence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-15
• Primary completion: 2025-07-30
• Completion: 2025-12-30
• First posted: 2024-07-26
• Last updated: 2025-02-28

Locations

1 site across 1 country: Canada