Evaluating the Effective and Safe Use of Stream™ Platform
NCT Number: NCT06522061
Acronym: Home-Stream
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: User-Centered Design|Anastomotic Leak|Colorectal Surgery|Artificial Intelligence
Interventions: DEVICE: Stream™ Platform
Sponsor: FluidAI Medical
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 25
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08-15
Completion Date: 2025-05-31
Locations: St. Paul's Hospital - Providence Healthcare (PHC), Vancouver, British Columbia, V6Z 1Y6, Canada

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.

Primary Outcome Measures: Evaluate if lay users can operate Stream Platform safely and effectively under healthcare providers supervision (simulated home use), 1. Statistical evaluation of the number of calibration errors encountered due to lay user error as reported by the healthcare providers.
2. Statistical evaluation of the number of calibration errors due to lay user errors that required intervention by the supervising healthcare provider to protect subject health and safety.
3. Occurrence of device associated adverse events including:

i. Adverse Device Events (ADE) ii. Serious Adverse Device Events (SADE) iii. Unanticipated Serious Adverse Device Events (USADE) iv. Device Deficiencies, Through study completion, an average of 6-months|Evaluate lay users' satisfaction through user feedback survey, Subject reported overall satisfaction with daily calibrations and overall device.

The following parameters will be recorded on a scale of 1-5:

1. System Related Feedback

   * Overall feedback on Stream Platform
   * Overall feedback on Stream Application
2. Training Related Feedback

   * Overall feedback on the instructions provided by Stream Application
   * Overall feedback on the training material provided including but not limited to training video, infographic, etc.
   * Overall feedback on the in-person training conducted
3. Subject Comfort Assessment

   * Overall subject experience performing ADLs (Activities of Daily Living) while Stream Platform is in use.
   * Overall subject experience sleeping while Stream Platform is in use, Through study completion, an average of 6-months
Secondary Outcome Measures: Utilize continuous pH and EC measurements collected prospectively using Stream™ Platform to supplement FluidAI's existing clinical model for early prediction of leakage after colorectal surgery., Data collected will be used to supplement Stream™ Platform's existing clinical model for early prediction of leakage., Through study completion, an average of 6-months|Identify correlations between measurements from Stream™ Platform and current standard of care (SOC)., Assess if any strong correlations exist between pH/EC measurement collected using FluidAI's Stream™ Platform and other diagnostic biomarkers for AL, Through study completion, an average of 6-months|Estimate the time taken by lay users to conduct calibration procedures, Quantify the average time taken by subjects/caregiver to conduct calibration in seconds as measured by the Stream™ Platform, Through study completion, an average of 6-months