Stream™ Platform for At-Home Monitoring

(Home-Stream Trial)

Overseen By Carl J Brown, BSc MSc MD FRCSC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: FluidAI Medical

Disqualifiers: Pregnancy, Delirium, Severe dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a monitoring device after surgery, so it's best to ask the trial staff for guidance.

What data supports the effectiveness of the Stream™ Platform treatment for at-home monitoring?

Research shows that remote monitoring, like the Stream™ Platform, can significantly reduce hospital readmissions for heart failure patients and improve outcomes for lung transplant recipients. These programs help detect health issues early and allow for timely intervention, which can lead to better health outcomes and lower healthcare costs. ^{1 2 3 4 5}

Is the Stream™ Platform for At-Home Monitoring generally safe for humans?

The available research discusses general methods for monitoring product safety and adverse events, but does not provide specific safety data for the Stream™ Platform. It is important to check with the trial organizers for any specific safety information related to this platform. ^{6 7 8 9 10}

How is the Stream™ Platform treatment unique compared to other treatments for at-home monitoring?

The Stream™ Platform is unique because it uses wearable sensors to continuously monitor vital signs like blood pressure and oxygen levels at home, allowing patients to move freely while their data is sent wirelessly to healthcare providers. This real-time remote monitoring is different from traditional methods that often require in-person visits or stationary equipment. ^{11 12 13 14 15}

Eligibility Criteria

This trial is for lay users or nonprofessional caregivers who will use the Stream™ Platform at home. It's designed to monitor patients after colorectal surgery and detect any complications like leaks. Participants should be able to follow device instructions.

Inclusion Criteria

I had surgery to connect two parts of my colon.

Subject/SDM understands and has voluntarily signed and dated Informed Consent Form (ICF)

I have a preventive drain placed after colorectal surgery.

Exclusion Criteria

I had surgery to fix a leak in my surgical connection.

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)

Subject was involved in the planning and conduct of the clinical investigation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Simulated Home Use

Lay users operate the Stream™ Platform in a simulated home-use environment to collect safety, efficacy, and usability data.

6 months

Continuous monitoring

Clinical Testing

Clinical testing to identify correlations between Stream™ Platform measurements and standard laboratory, radiological, and clinical assessments.

6 months

Follow-up

Participants are monitored for safety and effectiveness after the main study activities.

4 weeks

Treatment Details

Interventions

• Stream™ Platform

Trial Overview The Stream™ Platform is being tested for its effectiveness in monitoring patients remotely and safely post-surgery. The study compares data from this platform with standard lab, radiology, and clinical assessments.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

FluidAI Medical

Lead Sponsor

Trials

5

Recruited

630+

Findings from Research

The proposed three-part framework for analyzing adverse events includes phases for documenting incidents, conducting in-depth reviews, and assessing the association between exposure and adverse events, which can enhance product safety.

By standardizing the evaluation of adverse events through this framework, companies can better manage risks and improve consumer products based on reliable data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. Kingston, R., Sioris, K., Gualtieri, J., et al.[2022]

The safety profile of medications can change after they are approved for public use, as new safety issues may arise that were not identified during clinical trials.

Regulatory agencies, like the FDA, actively monitor medication safety through various methods, including analyzing adverse experience reports and using large electronic databases to detect potential safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. Sharrar, RG., Dieck, GS.[2021]

In a study analyzing the performance of five different alerting algorithms for monitoring drug safety, it was found that no single algorithm was superior across all scenarios, highlighting the need for tailored approaches based on specific product-outcome characteristics.

The algorithms successfully identified cases of rhabdomyolysis linked to cerivastatin before the drug was withdrawn, demonstrating their potential effectiveness in active medical-product-safety surveillance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active safety monitoring of new medical products using electronic healthcare data: selecting alerting rules. Gagne, JJ., Rassen, JA., Walker, AM., et al.[2021]

AdEPro is an interactive app designed to simplify the exploration of adverse event data from clinical trials, allowing users to visualize data on individual subjects and treatment groups without needing extensive programming skills.

The app serves as a 'hypothesis generator' for users to quickly investigate questions about adverse events, such as their onset and severity, while ensuring that patient data is processed locally for privacy and security.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AdEPro: Animation of Adverse Event Profiles-Presentation of an Easy-to-Use App for Visually Exploring Individual Study Data. Mentenich, N., Tasto, C., Becker, B.[2021]

The platform developed for home care providers incorporates telemonitoring features, which became increasingly important during the COVID-19 pandemic to ensure patient safety and continuous care.

This integration allows for better monitoring of patients' health remotely, potentially improving outcomes and reducing the need for in-person visits during times of health crises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usage of a Web-Based Platform for Home Care Providers in the Pandemic Context. Sandulescu, V., Puscoci, S., Petre, M., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Applications of Remote Patient Monitoring. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A new paradigm for telehealth implementation. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Use of a Bluetooth tablet-based technology to improve outcomes in lung transplantation: A pilot study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Smart home-based health platform for behavioral monitoring and alteration of diabetes patients. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Home monitoring cuts cardiac readmissions. [2011]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Active safety monitoring of new medical products using electronic healthcare data: selecting alerting rules. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

AdEPro: Animation of Adverse Event Profiles-Presentation of an Easy-to-Use App for Visually Exploring Individual Study Data. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Consensus building for development of outpatient adverse drug event triggers. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Cellular telephones measure activity and lifespace in community-dwelling adults: proof of principle. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

The next generation of mobile medication management solutions. [2017]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Usage of a Web-Based Platform for Home Care Providers in the Pandemic Context. [2021]

14. Germany pubmed.ncbi.nlm.nih.gov

[@HOME is a new Eu-Project in Tele Home care]. [2006]

15. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of the Wearable Sensor-based Ambient Intelligent Geriatric Management (AmbIGeM) System in Preventing Falls in Older People in Hospitals. [2022]