Wireless Shunt Flow Measurement Device for Hydrocephalus

Recruiting in Chicago (>99 mi)

+2 other 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

Trial Summary

What is the purpose of this trial?

This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.

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 data supports the effectiveness of the Wireless Thermal Anisotropy Measurement Device treatment for hydrocephalus?

Research shows that wireless and noninvasive devices using thermal measurement can effectively monitor cerebrospinal fluid flow in shunts, helping to detect shunt failures in hydrocephalus patients. These devices have been shown to reduce hospital visits and anxiety for caretakers by allowing at-home monitoring, and they have demonstrated high performance in clinical studies. ^{1 2 3 4 5}

Is the Wireless Shunt Flow Measurement Device for Hydrocephalus safe for humans?

The Wireless Shunt Flow Measurement Device, also known as the Thermal Anisotropy Measurement Device, has been tested in clinical studies involving patients with hydrocephalus. These studies show that the device can safely monitor cerebrospinal fluid flow in shunts, with no significant safety concerns reported during the trials. ^{1 3 4 5 6}

How does the Wireless Shunt Flow Measurement Device for Hydrocephalus differ from other treatments?

This treatment is unique because it uses a wireless, wearable device to continuously and noninvasively monitor the flow of cerebrospinal fluid (CSF) through shunts, unlike traditional methods that are invasive or require expensive imaging. It provides real-time data and can be used in various settings, including at home, offering a more convenient and accurate way to detect shunt malfunctions. ^{3 4 5 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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 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]

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]

References

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

Optimization of a Thermal Flow Meter for Failure Management of the Shunt in Pediatric Hydrocephalus Patients. [2021]

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

Noninvasive thermal evaluation for shunt failure in the emergency room. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Continuous, noninvasive wireless monitoring of flow of cerebrospinal fluid through shunts in patients with hydrocephalus. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Multimodal Sensing Capabilities for the Detection of Shunt Failure. [2021]

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

Epidermal electronics for noninvasive, wireless, quantitative assessment of ventricular shunt function in patients with hydrocephalus. [2019]

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

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

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

Evaluation of the ShuntCheck noninvasive thermal technique for shunt flow detection in hydrocephalic patients. [2010]

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

A noninvasive approach to quantitative measurement of flow through CSF shunts. Technical note. [2003]