Wireless Shunt Flow Measurement Device for Hydrocephalus

Recruiting at 2 trial locations

Overseen By Anna Somera

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Rhaeos, Inc.

Disqualifiers: Open wound, Skin reactions, others

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

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device that measures cerebrospinal fluid (CSF) shunt performance without surgery. It targets individuals with a shunt for hydrocephalus, a condition characterized by excess fluid in the brain. Participants will use the Thermal Anisotropy Measurement Device to monitor their shunt's performance over time. The trial suits those with a shunt, intact skin over it, and the ability to stay in the hospital or follow instructions for home use. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance non-invasive 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 the use of a device to measure shunt flow, so it's best to ask the study team for guidance.

What prior data suggests that this device is safe for measuring CSF shunt flow?

Research has shown that the Thermal Anisotropy Measurement Device safely checks the flow of cerebrospinal fluid (CSF) shunts without surgery. Past studies found that patients generally tolerate the device well, with no major reports of adverse side effects. Worn on the skin, the device requires no surgery, thus posing a low risk of harm. This makes it a safe choice for patients with an implanted shunt. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for hydrocephalus involve surgically implanted shunts to drain excess cerebrospinal fluid and require regular monitoring for proper function. However, the Wireless Shunt Flow Measurement Device is unique because it offers a non-invasive way to measure shunt flow using a technique called thermal anisotropy. This device allows for real-time, wireless monitoring of shunt function without additional surgeries or hospital visits, potentially reducing complications and improving patient quality of life. Researchers are excited about this trial because it could lead to safer, more efficient management of hydrocephalus, making life easier for both patients and healthcare providers.

What evidence suggests that this device is effective for measuring shunt flow in hydrocephalus?

Studies have shown that the Thermal Anisotropy Measurement Device, used by participants in this trial, effectively measures cerebrospinal fluid (CSF) flow in patients with shunts. This non-invasive device operates from outside the body and is placed on the skin above the shunt. Research indicates that this wearable sensor accurately detects CSF shunt flow in symptomatic patients. Initial findings suggest it performs well in everyday situations, such as during daily activities and sleep. This makes it a promising tool for monitoring shunt performance without requiring surgery or other invasive procedures. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for people aged 6-80 with hydrocephalus who have a ventriculoperitoneal CSF shunt and intact skin where the device will be placed. Participants must speak English, provide consent, and be available for follow-ups. Minors over 12 must give verbal assent.

Inclusion Criteria

I have a clear skin area over my long-term ventricular shunt near my collarbone for the study device.

You or a legally appointed representative have given your permission for the study to proceed.

I can attend follow-ups in-person or remotely for 30 days while using the study device at home.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Assessment

Participants wear the non-invasive device to acquire longitudinal data on cerebrospinal fluid shunt flow

12 weeks

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after device assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Thermal Anisotropy Measurement Device

Trial Overview The study tests a new device that measures cerebrospinal fluid flow in shunts non-invasively. Patients with existing shunts wear the device to collect data over time, both at home and possibly in a hospital setting.

How Is the Trial Designed?

Group I: Feasibility Assessment Cohort Experimental Treatment 1 Intervention

Non-invasive device data acquisition; study is not interventional

Who Is Running the Clinical Trial?

Rhaeos, Inc.

Lead 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]

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]

The ShuntCheck device demonstrated high sensitivity (80%) and specificity (100%) in detecting cerebrospinal fluid flow in malfunctioning shunts, based on a study of 100 shunted patients, including 48 with suspected malfunctions.

While the device effectively identifies flow in malfunctioning shunts, it does not reliably predict the need for surgical intervention, as many patients without detectable flow did not require shunt revision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the ShuntCheck noninvasive thermal technique for shunt flow detection in hydrocephalic patients. Madsen, JR., Abazi, GS., Fleming, L., et al.[2010]

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]

A new noninvasive method for measuring flow rate through cerebrospinal fluid (CSF) shunts uses thermistors placed on the skin, which respond to temperature changes caused by ice applied over the shunt tubing.

Animal experiments demonstrated that this method accurately correlates calculated flow rates with actual infusion rates, suggesting it could be effectively adapted for use in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A noninvasive approach to quantitative measurement of flow through CSF shunts. Technical note. Stein, SC., Apfel, S.[2003]

A retrospective case series involving 8 patients with suspected ventriculoperitoneal shunt (VPS) malfunction demonstrated that a thermal sensor can effectively assess shunt flow, helping to determine the need for intervention.

The thermal diffusion technique allowed for quick evaluations, leading to appropriate decisions: 3 patients were discharged with adequate flow, while 2 with poor flow were admitted for shunt revision, highlighting its utility in emergency settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive thermal evaluation for shunt failure in the emergency room. Xu, J., Poole, C., Sahyouni, R., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07050628

Study Details | NCT07050628 | Assessment of CSF Shunt ... Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device. ClinicalTrials.gov ID NCT07050628.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06410885

Assessment of Flow in Cerebrospinal Fluid Shunts With a ... The study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal ...

3. rhaeos.com rhaeos.com/wp-content/uploads/2025/06/Limbrick-2025.pdf

A Multicenter Study of Noninvasive Wireless Assessment of ... CONCLUSION: This study established the performance of a first-generation wearable thermal anisotropy sensor in the identification of CSF shunt ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40522244/

A Multicenter Study of Noninvasive Wireless Assessment ... This study established the performance of a first-generation wearable thermal anisotropy sensor in the identification of CSF shunt flow in symptomatic patients.

5. trialx.com trialx.com/clinical-trials/listings/225534/formative-usability-assessment-of-wireless-thermal-anisotropy-devices/

Formative Usability Assessment of Wireless Thermal ... This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements. Eligibility.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06086561

Longitudinal Measurements of Flow in Cerebrospinal Fluid ... This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt ...

7. nature.com nature.com/articles/s41746-020-0239-1

Continuous, noninvasive wireless monitoring of flow ... We introduce a wireless, wearable device that enables precise measurements of CSF flow, continuously or intermittently, in hospitals, laboratories or even in ...

8. withpower.com withpower.com/trial/phase-hydrocephalus-10-2023-cd4fd

Wireless Shunt Flow Measurement Device for Hydrocephalus This N/A medical study run by Rhaeos, Inc. is evaluating whether Thermal Anisotropy Measurement Device will have tolerable side effects & efficacy for ...

9. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06410885

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