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

Trial Summary

What is the purpose of this 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 and surgeries by providing an easy way to check if the treatment is working. The sensor sends data to a mobile app, making it simple for doctors to keep track of the patient's condition.

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 data supports the idea that FlowSense Monitoring for Hydrocephalus is an effective treatment?

The available research shows that FlowSense Monitoring for Hydrocephalus is effective because it provides precise and continuous monitoring of cerebrospinal fluid flow, which helps in detecting shunt malfunctions early. This is important because shunts have a high failure rate, and early detection can prevent complications. Compared to other methods like CT scans or MRIs, FlowSense is noninvasive, more convenient, and safer. Studies involving patients have shown that FlowSense can accurately detect changes in fluid flow, which helps in managing the condition better and reduces unnecessary hospital visits. ^{1 2 3 4 5}

What data supports the effectiveness of the FlowSense treatment for hydrocephalus?

Research shows that the FlowSense treatment, which includes a wireless, wearable device, can accurately monitor the flow of cerebrospinal fluid (CSF) in patients with hydrocephalus. Studies involving patients have demonstrated its ability to detect changes in CSF flow, helping to identify shunt malfunctions and potentially reducing unnecessary hospital visits. ^{1 2 3 4 5}

What safety data exists for FlowSense Monitoring for Hydrocephalus?

The safety data for FlowSense Monitoring, also known as FlowSense Shunt Monitor or Wireless Non-Invasive Thermal Flow Sensor, includes several studies demonstrating its functionality and safety. Clinical studies involving patients have shown the device's ability to detect cerebrospinal fluid (CSF) flow and distinguish between different flow conditions. The device has been tested in various settings, including hospitals and home environments, and has been validated for its noninvasive, wireless monitoring capabilities. Additionally, the device has received 510(k) clearance from the FDA, indicating it meets safety and effectiveness standards for detecting flow in CSF shunts. Overall, the studies suggest that the device is a safe and effective tool for monitoring shunt function in hydrocephalus patients. ^{1 2 3 4 6}

Is the FlowSense Monitoring for Hydrocephalus safe for humans?

The FlowSense Monitoring device, also known as the FlowSense Shunt Monitor or Wireless Non-Invasive Thermal Flow Sensor, has been tested on patients and shown to be safe for monitoring cerebrospinal fluid flow in shunts. Clinical studies involving patients have demonstrated its ability to detect flow without the safety concerns associated with other diagnostic tools like CT or MRI scans. ^{1 2 3 4 6}

Is FlowSense Monitoring for Hydrocephalus a promising treatment?

Yes, FlowSense Monitoring is a promising treatment for hydrocephalus. It offers a noninvasive, wireless way to continuously monitor the flow of cerebrospinal fluid in patients with shunts. This technology can help detect shunt malfunctions early, reducing unnecessary hospital visits and stress for patients and caregivers. It is user-friendly and can be used at home, making it a valuable tool for managing hydrocephalus. ^{1 2 3 4 7}

How does the FlowSense Monitoring treatment for hydrocephalus differ from other treatments?

FlowSense Monitoring 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 rely on imaging or invasive procedures. This technology allows for real-time monitoring at home or in clinical settings, reducing the need for hospital visits and exposure to radiation. ^{1 2 3 4 7}

Research Team

Samuel McClugage, MD

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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, 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]

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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

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

A wireless monitoring system for Hydrocephalus shunts. [2020]

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

A portable multi-sensor module for monitoring external ventricular drains. [2022]