FlowSense® for Hydrocephalus

Overseen By Anna Lisa Somera

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Rhaeos, Inc.

Disqualifiers: Multiple shunt catheters, Open wound, 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 a new device called FlowSense®, which helps doctors assess the function of a cerebrospinal fluid shunt without invasive procedures. The study aims to determine if the device can accurately predict when the shunt is functioning properly and to observe any changes in medical visits and imaging needs. It suits individuals who already have a brain fluid shunt and are undergoing regular check-ups without current shunt issues.

As an unphased trial, this study allows patients to contribute to innovative research that could simplify and improve future shunt monitoring.

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 evaluating a device for monitoring shunt flow, so it's unlikely to require changes to your medication.

What prior data suggests that the FlowSense® device is safe for assessing CSF shunt flow?

In a previous study, the FDA approved the FlowSense® device, confirming it meets safety and effectiveness standards for detecting cerebrospinal fluid (CSF) flow in shunts. FlowSense® is a wireless sensor placed on the neck to measure CSF flow without surgery.

Studies have reported no serious side effects. However, some patients experienced minor skin reactions to the adhesives used with the device, suggesting it is generally well-tolerated. Participants should inform the researchers of any concerns, such as open wounds where the device will be placed, as these could affect its use. Overall, the FlowSense® device appears safe, especially given its FDA approval and noninvasive design. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about FlowSense® for hydrocephalus because it offers a novel way to monitor cerebrospinal fluid dynamics, which is crucial for managing this condition effectively. Unlike traditional shunt systems, which can be invasive and prone to complications, FlowSense® provides a non-invasive, real-time diagnostic tool that could improve patient outcomes by allowing for more precise adjustments to treatment strategies. This innovation could lead to fewer surgical interventions and better long-term management of hydrocephalus.

What evidence suggests that the FlowSense® device is effective for assessing cerebrospinal fluid shunt flow in hydrocephalus?

Studies have shown that FlowSense effectively and continuously monitors cerebrospinal fluid (CSF) flow in patients with hydrocephalus. The trial consists of two parts: an observational, blinded phase and a diagnostic, unblinded phase, both using the FlowSense device. This user-friendly sensor detects shunt problems, preventing delays in testing. The FDA has granted FlowSense Breakthrough Device designation, recognizing its potential to enhance patient care. Early results suggest that the device helps manage hydrocephalus more efficiently by enabling quicker responses to issues. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people aged 2 or older with a working ventricular cerebrospinal fluid shunt and no current concerns for malfunction. They must have intact skin where the device will be placed and either give consent themselves or through a guardian.

Inclusion Criteria

I am at least 2 years old.

I have a shunt for draining fluid from my brain.

I have a clear area of skin over my long-term ventricular shunt.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational, part 1 (blinded)

Subjects with an existing implanted ventricular CSF shunt are evaluated with the study device to determine the negative predictive value (NPV) in a blinded fashion.

Up to 7 days

Diagnostic, part 2 (unblinded)

Exploration of changes in surveillance imaging, health resource utilization, and visit duration during routine follow-up visits with the study device in an unblinded fashion.

Follow-up

Participants are monitored for safety and effectiveness after treatment, including intraoperative observations for any surgery performed per the standard of care.

7 days

What Are the Treatments Tested in This Trial?

Interventions

• FlowSense®

Trial Overview The study tests FlowSense®, a non-invasive sensor to check cerebrospinal fluid flow in patients with shunts. It aims to determine its accuracy (Part 1) and impact on routine follow-up care (Part 2).

How Is the Trial Designed?

Group I: Observational, part 1 (blinded) Experimental Treatment 1 Intervention

Group II: Diagnostic, part 2 (unblinded) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Rhaeos, Inc.

Lead Sponsor

Trials

11

Recruited

690+

Citations

1. withpower.com withpower.com/trial/phase-hydrocephalus-2023-fcbef

FlowSense Monitoring for Hydrocephalus (RHAEOS Trial) The available research shows that FlowSense Monitoring for Hydrocephalus is effective because it provides precise and continuous monitoring of cerebrospinal ...

2. withpower.com withpower.com/trial/flowsense-for-hydrocephalus-d6382

FlowSense® for Hydrocephalus · Info for Participants This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow.

3. fluidsbarrierscns.biomedcentral.com fluidsbarrierscns.biomedcentral.com/articles/10.1186/s12987-024-00596-8

Abstracts from Hydrocephalus 2024: The 16th Meeting of the ... Data encompassing demographics, surgical specifics, complications and outcomes were collected and evaluated. Results: The median age of the ...

4. hydroassoc.org hydroassoc.org/rhaeos-awarded-nih-grant-for-flowsense/

Rhaeos Sensor to Detect Hydrocephalus Shunt Failure Grant advances their development of FlowSense, a wearable sensor that detects failed shunts in patients with hydrocephalus.

5. prnewswire.com prnewswire.com/news-releases/rhaeos-inc-receives-fda-breakthrough-device-designation-for-flowsense-noninvasive-thermal-sensor-301068151.html

Rhaeos, Inc. Receives FDA Breakthrough Device ... "FlowSense noninvasively detects cerebrospinal fluid shunt flow, which can potentially eliminate delays with diagnostic testing and expedite ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05546996

EVD Drainage Data and Intracranial Pressure (ICP) ... FlowSense, is a wireless, noninvasive thermal flow sensor that can be mounted on a patient's neck overlying the shunt to detect the presence and magnitude of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7060317/

Continuous, noninvasive wireless monitoring of flow ... Measurements on 7 patients establish high levels of functionality, with data that reveal time dependent changes in flow associated with ...

8. rhaeos.com rhaeos.com/flowsense/

About FlowSense FlowSense is a wireless, noninvasive thermal flow sensor that can be mounted on a patient's neck overlying the shunt to detect the presence and magnitude of ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT06506045

Functional and Non-Functional CSF Shunt Flow Measured ... Presence of an interfering open wound or edema in the FlowSense device measurement area; Patient-reported history of adverse skin reactions to adhesives ...