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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Stream™ Platform, a device for at-home monitoring of patients after colorectal surgery. The goal is to determine if patients can use the device easily and safely while it measures important health signs, such as pH levels in abdominal fluid. The study compares these device measurements with traditional hospital tests to potentially reduce unnecessary hospital stays. Individuals who have undergone colorectal surgery, have a drain placed, and have not yet shown complications might be suitable candidates for this trial.

As an unphased trial, participation offers the opportunity to contribute to innovative healthcare solutions and potentially improve post-surgery recovery experiences.

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 prior data suggests that the Stream™ Platform is safe for at-home monitoring?

Research has shown that home monitoring devices, like the Stream™ Platform, are generally safe for users. In earlier studies, participants used the Stream™ Platform in a mock home setting to test its safety and ease of use. These studies evaluated the device's functionality and user proficiency.

The studies did not identify any specific safety issues, indicating that non-professionals can use the device without major problems. The Stream™ Platform monitors patients outside of hospitals by providing continuous information about abdominal drain fluid. This remote monitoring is designed to be secure and user-friendly.

Privacy remains crucial with these devices, as they collect sensitive health information that requires protection. Overall, evidence suggests that the Stream™ Platform is safe and easy to use at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stream™ Platform because it offers a new way to monitor patients at home by attaching to abdominal or pelvic drains. Unlike traditional methods that might require frequent hospital visits or manual checks, this platform continuously measures pH and electrical conductivity in real-time. This could lead to faster identification of complications and more personalized patient care, reducing the need for hospital stays and enhancing convenience.

What evidence suggests that the Stream™ Platform is effective for at-home monitoring?

Research shows that remote patient monitoring (RPM), such as the Stream™ Platform, can lead to better health outcomes. Studies have found that RPM improves safety and ensures patients adhere to their treatment plans more consistently. This monitoring also enhances movement and daily functioning, which are crucial for overall health. In this trial, the Stream™ Platform will monitor patients at home by checking the pH and electrical conductivity in fluid from abdominal drains. This data-driven approach aims to provide more effective care and instills greater confidence in patients regarding their treatment. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

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

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-user-centered-design-7-2024-cda6d

Stream™ Platform for At-Home Monitoring Simulated Home Use. Lay users operate the Stream™ Platform in a simulated home-use environment to collect safety, efficacy, and usability data. 6 months.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11258279/

A systematic review of the impacts of remote patient ... RPM interventions demonstrated positive outcomes in patient safety and adherence. RPM interventions also improved patients' mobility and functional statuses.

3. healthsnap.io healthsnap.io/9-benefits-of-remote-patient-monitoring-platforms/

9 Benefits of Remote Patient Monitoring Platforms Data-Driven Care Helps Improve Health Outcomes · Better Patient Compliance Makes Treatments More Effective · Higher Level of Patient Assurance, ...

4. mhealth.jmir.org mhealth.jmir.org/2023/1/e37347

Health Monitoring Using Smart Home Technologies Smart home technology employs the Internet of Things (IoT) concept to interconnect and share data among household devices across a Wi-Fi–based ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2468227623000959

Remote patient monitoring systems: Applications, ... In this paper, we present a detailed of various existing RPMS with areas of focus on their application, architecture, technology applied, and challenges faced.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7435203/

Regulatory, safety, and privacy concerns of home ... Home monitoring technologies raise privacy concerns, since they collect people's health-related data that are sensitive and need to be ...

7. psnet.ahrq.gov psnet.ahrq.gov/perspective/remote-patient-monitoring

Remote Patient Monitoring | PSNet - AHRQ RPM is a type of telehealth in which healthcare providers monitor patients outside the traditional care setting using digital medical devices.

8. chcf.org chcf.org/resource/remote-patient-monitoring-safety-net-payers-providers-need-know/

Remote Patient Monitoring in the Safety Net: What Payers ... RPM is a type of telehealth that involves the secure transfer of personal health and medical data to a provider for remote monitoring, care, and support.

9. obviohealth.com obviohealth.com/resources/obviohealth-and-oracle-life-sciences-expand-global-partnership

ObvioHealth and Oracle Life Sciences Expand Global ... “Enabling patients to report important safety data remotely via ObvioGo's e-diary resulted in more accurate, real-time information. In other ...