Evaluating the Effective and Safe Use of Stream™ Platform (Home-Stream)

February 26, 2025 updated by: FluidAI Medical

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital - Providence Healthcare (PHC)
        • Contact:
        • Contact:
        • Contact:
          • Carl J Brown, BSc MSc MD FRCSC
        • Contact:
          • Elizabeth Clement, BSc MSc MD FRCSC
        • Contact:
          • Amandeep (Anu) Ghuman, BSc MD MPH FRCSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years - male or female.
  • Subject/SDM understands and has voluntarily signed and dated Informed Consent Form (ICF).
  • Subject underwent colorectal surgery with anastomosis.
  • Subjects must be willing to comply with trial requirements.
  • Subject has a prophylactic abdominal/pelvic drain after colorectal surgery.

Exclusion Criteria:

  • Subjects/caregiver is unwilling or unable to comply with the requirements of the protocol.
  • 24 hours or more have passed since the end of the subject's surgery and consent was not attained.
  • The subject had already developed an anastomotic leak at the time of screening and underwent surgery for treatment of the complication.
  • Plans that the subject will be discharged in less than 3 days post-surgery.
  • Subject has reported that they are pregnant.
  • Subject has a permanent end stoma.
  • Subject is delirious.
  • Subject has severe dementia.
  • Subject was involved in the planning and conduct of the clinical investigation.
  • Origin™ is not compatible with the drain used on the subject.
  • Subject and/or caregiver is/are not capable of conducting the calibrations for Stream™ Platform (this can be self-reported or determined by the CRC/HCP/other research staff).
  • The subject and/or caregiver is/are unable to understand the instructions provided for the management and calibration of Stream™ Platform (this can be self-reported or determined by the CRC/investigator/other research staff).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm

Stream™ Platform will be attached to the abdominal/pelvic drains of the patients enrolled in this group. The platform will conduct continuous pH and electrical conductivity measurements of the abdominal drain fluid.

All subjects recruited will take part in the evaluation of Stream™ Platform in a simulated home-use environment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate if lay users can operate Stream Platform safely and effectively under healthcare providers supervision (simulated home use)
Time Frame: Through study completion, an average of 6-months
  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
Time Frame: Through study completion, an average of 6-months

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

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Through study completion, an average of 6-months
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).
Time Frame: Through study completion, an average of 6-months
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
Time Frame: Through study completion, an average of 6-months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FluidAI Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2025

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLS0009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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