FlowSense Monitoring for Hydrocephalus

(RHAEOS Trial)

Overseen By Sarah Martinez

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: No external ventricular drains

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for monitoring brain fluid flow in individuals with hydrocephalus, a condition where excess fluid accumulates in the brain. The new tool, FlowSense, is a small, bandage-like device placed on the neck that sends data to a mobile app, simplifying the process of checking fluid drainage. The goal is to detect issues early, reducing the need for emergency room visits or additional surgeries. This trial may suit those with a shunt and an external ventricular drain, a tube that helps drain fluid from the brain. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could simplify monitoring for hydrocephalus patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the FlowSense device is safe for monitoring hydrocephalus?

Research shows that FlowSense is a noninvasive and easy-to-use device. It operates without entering the body and is as simple as placing a bandage on the neck over a shunt, making it safer and more comfortable than many other medical devices.

Early results indicate that patients tolerate FlowSense well, with no reports of serious side effects directly linked to its use. Made of soft silicone and wireless, the device prevents discomfort and enhances user experience.

Additionally, since FlowSense only monitors and does not alter anything in the body, the safety risks remain low. It measures the flow of cerebrospinal fluid (CSF) through the shunt and sends the information to a mobile app, reducing the need for more invasive procedures or frequent hospital visits.

In summary, FlowSense appears to be a safe and easy-to-use option for monitoring shunt function in patients with hydrocephalus. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FlowSense Monitoring for Hydrocephalus trial because it aims to enhance the management of hydrocephalus by providing real-time data on cerebrospinal fluid (CSF) flow rates. Unlike traditional methods that often rely on intermittent and sometimes subjective measurements, FlowSense offers continuous and objective flow rate data. This could lead to more precise adjustments in treatment for hydrocephalus patients, potentially improving outcomes and reducing complications associated with current monitoring techniques. By correlating FlowSense data with existing intracranial pressure measurements and external ventricular drainage (EVD) data, researchers hope to establish a more reliable and comprehensive monitoring system.

What evidence suggests that the FlowSense device is effective for monitoring hydrocephalus?

Research has shown that FlowSense is promising for monitoring cerebrospinal fluid (CSF) flow in people with hydrocephalus. This easy-to-use sensor checks the flow in shunts, which are tubes that help drain extra fluid from the brain. Participants in this trial will engage in different phases to evaluate FlowSense's effectiveness. Studies indicate that FlowSense can effectively track shunt performance, potentially reducing the need for hospital visits and imaging tests. By providing accurate, real-time information, FlowSense aims to detect shunt problems early, which may lower emergency room visits and repeat surgeries. These early findings suggest that FlowSense could significantly advance hydrocephalus management. ^{1 2 3 5 6}

Who Is on the Research Team?

Samuel McClugage, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for patients who have hydrocephalus and currently have one or more external ventricular drains (EVDs) in place. It's not suitable for those without any EVDs.

Inclusion Criteria

Patients with one or more existing external ventricular drains (EVDs)

Exclusion Criteria

Patients with no external ventricular drains (EVDs)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase A

Establish suitability of digital video recording system for quantifying CSF drainage into an EVD drainage system

1 year

Phase B

Exploratory study to generate initial data on the correlation between FlowSense flow rate measurements and EVD drainage data, and intracranial pressure measurements

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• FlowSense

Trial Overview The trial is testing FlowSense, a wireless, noninvasive device that monitors cerebrospinal fluid flow through shunts to detect blockages or malfunctions without the need for complex equipment.

How Is the Trial Designed?

Group I: Phase B Experimental Treatment 1 Intervention

Exploratory study to generate initial data on the correlation between FlowSense flow rate measurements (FlowSense Flow Rate) and: A) EVD drainage data, quantified via video recording; B) intracranial pressure (ICP) measurements

Group II: Phase A: Active Control 1 Intervention

Establish suitability of digital video recording system for quantifying CSF drainage into an EVD drainage system.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Rhaeos, Inc.

Industry Sponsor

Trials

11

Recruited

690+

Published Research Related to This Trial

A new wireless, wearable device has been developed to accurately measure cerebrospinal fluid (CSF) flow in patients with hydrocephalus, addressing the challenges of diagnosing shunt malfunctions.

In tests with 7 patients, the device demonstrated high functionality and revealed important changes in CSF flow related to body position, indicating its potential for practical use in various settings and for research on CSF dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous, noninvasive wireless monitoring of flow of cerebrospinal fluid through shunts in patients with hydrocephalus. Krishnan, SR., Arafa, HM., Kwon, K., et al.[2023]

Hydrocephalus patients often face challenges in managing their condition due to vague symptoms associated with shunt failures, leading to unnecessary emergency healthcare visits and increased stress for caregivers.

The proposed implantable thermal flow meter could significantly improve the monitoring of cerebrospinal fluid flow in shunts, allowing patients to track their shunt function at home, which may reduce hospital visits and caregiver anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimization of a Thermal Flow Meter for Failure Management of the Shunt in Pediatric Hydrocephalus Patients. Charles Chen, Z., Gary, A., Gupta, V., et al.[2021]

A new soft, wireless device has been developed to monitor cerebrospinal fluid (CSF) flow in patients with hydrocephalus, which can help detect complications related to shunt devices, such as infection or obstruction.

This device uses flow sensors and electrodes to provide precise, real-time measurements of CSF flow rate, and it can communicate with smartphones via Bluetooth, potentially improving patient management and reducing the need for emergency interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal Sensing Capabilities for the Detection of Shunt Failure. Gamero, M., Kim, WS., Hong, S., et al.[2021]

A new noninvasive, wearable measurement platform has been developed to monitor cerebrospinal fluid (CSF) flow through subdermal shunts, addressing the limitations of current diagnostic methods for shunt failure, which include high costs and safety concerns.

Clinical trials with five patients demonstrated that this wearable sensor can accurately detect CSF flow and differentiate between normal and diminished flow, showing promise for improving hydrocephalus diagnostics in a user-friendly manner.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidermal electronics for noninvasive, wireless, quantitative assessment of ventricular shunt function in patients with hydrocephalus. Krishnan, SR., Ray, TR., Ayer, AB., et al.[2019]

The integrated multi-sensor module (IMSM) significantly improves the monitoring of cerebrospinal fluid (CSF) drainage through external ventricular drains (EVDs) by providing automated, high-resolution tracking of flow rates, reducing error by a factor of 6.6 compared to previous methods.

The IMSM includes advanced sensors for flow, temperature, and integrity, and has been tested successfully for 53 days, demonstrating its reliability and potential for enhancing clinical outcomes in managing brain fluid pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A portable multi-sensor module for monitoring external ventricular drains. Hudson, TQ., Baldwin, A., Samiei, A., et al.[2022]

A new noninvasive method for measuring flow in cerebrospinal fluid (CSF) shunts was developed, successfully detecting flow in 9 out of 10 attempts during clinical testing.

This method received FDA 510(k) clearance and offers predictive values equal to or better than traditional brain imaging and radionuclide studies, making it a cost-effective alternative for monitoring CSF shunt function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement of flow of cerebrospinal fluid in shunts by transcutaneous thermal convection. Technical note. Neff, S.[2007]

A new wireless monitoring system using pressure sensors has been developed to detect clogs and measure flow rates in shunts used for treating hydrocephalus, addressing a major cause of shunt failure.

The system can accurately measure flow rates with over 90% accuracy, allowing for timely adjustments to prevent complications like over or under drainage of cerebrospinal fluid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A wireless monitoring system for Hydrocephalus shunts. Narayanaswamy, A., Nourani, M., Tamil, L., et al.[2020]

Citations

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

Continuous, noninvasive wireless monitoring of flow ... Taken together, the results suggest a significant advance in monitoring capabilities for patients with shunted hydrocephalus, with potential for ...

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

FlowSense Monitoring for Hydrocephalus (RHAEOS Trial) This trial is testing FlowSense, a small, wireless sensor that helps monitor fluid flow in patients with hydrocephalus. It aims to reduce hospital visits ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06410885

Assessment of Flow in Cerebrospinal Fluid Shunts With a ... This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Subjects with ...

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. 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 CSF ...

6. reporter.nih.gov reporter.nih.gov/project-details/10930877

Development of wireless, wearable flow sensors for ... Development of wireless, wearable flow sensors for continuous, long-term tracking of cerebrospinal fluid dynamics in patients with hydrocephalus.