Wireless Shunt Flow Measurement Device for Hydrocephalus
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Rhaeos, Inc.
Disqualifiers: Open wound, Skin reactions, others
No Placebo Group
Approved in 1 Jurisdiction
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.
12345Is 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.
13456How 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.
34578Eligibility 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.
+5 more
Trial 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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Feasibility Assessment CohortExperimental Treatment1 Intervention
Non-invasive device data acquisition; study is not interventional
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Tampa Marriott Water StreetTampa, FL
MATTERChicago, IL
Northwest Special Recreation AssociationRolling Meadows, IL
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Who Is Running the Clinical Trial?
Rhaeos, Inc.Lead Sponsor
References
Optimization of a Thermal Flow Meter for Failure Management of the Shunt in Pediatric Hydrocephalus Patients. [2021]Hydrocephalus patients suffer from an abnormal buildup of cerebrospinal fluid (CSF) in their ventricles, and there is currently no known way to cure hydrocephalus. The most prevalent treatment for managing hydrocephalus is to implant a ventriculoperitoneal shunt, which diverts excess CSF out of the brain. However, shunts are prone to failure, resulting in vague symptoms. Our patient survey results found that the lack of specificity of symptoms complicates the management of hydrocephalus in the pediatric population. The consequences include persistent mental burden on caretakers and a significant amount of unnecessary utilization of emergency healthcare resources due to the false-positive judgement of shunt failure. In order to reliably monitor shunt failures for hydrocephalus patients and their caretakers, we propose an optimized design of the thermal flow meter for precise measurements of the CSF flow rate in the shunt. The design is an implantable device which slides onto the shunt and utilizes sinusoidal heating and temperature measurements to improve the signal-to-noise ratio of flow-rate measurements by orders of magnitude.Clinical Relevance- An implantable flow meter would be transformative to allow hydrocephalus patients to monitor their shunt function at home, resulting in reduced hospital visits, reduced exposure to radiation typically required to rule out shunt failure, and reduced caretaker anxiety.
Noninvasive thermal evaluation for shunt failure in the emergency room. [2022]Ventriculoperitoneal shunts (VPSs) have been the mainstay of treating hydrocephalus since the 1950s. However, shunts have a reported complication rate reaching nearly 50%. Devices have been developed that utilize noninvasive thermal transcutaneous diffusion technology. These shunt evaluation devices measure temperature gradients to detect shunt cerebrospinal fluid flow. We assessed the utility using a thermal diffusion technique to work up shunt failure in the emergency room (ER).
Continuous, noninvasive wireless monitoring of flow of cerebrospinal fluid through shunts in patients with hydrocephalus. [2023]Hydrocephalus is a common disorder caused by the buildup of cerebrospinal fluid (CSF) in the brain. Treatment typically involves the surgical implantation of a pressure-regulated silicone tube assembly, known as a shunt. Unfortunately, shunts have extremely high failure rates and diagnosing shunt malfunction is challenging due to a combination of vague symptoms and a lack of a convenient means to monitor flow. Here, we introduce a wireless, wearable device that enables precise measurements of CSF flow, continuously or intermittently, in hospitals, laboratories or even in home settings. The technology exploits measurements of thermal transport through near-surface layers of skin to assess flow, with a soft, flexible, and skin-conformal device that can be constructed using commercially available components. Systematic benchtop studies and numerical simulations highlight all of the key considerations. Measurements on 7 patients establish high levels of functionality, with data that reveal time dependent changes in flow associated with positional and inertial effects on the body. Taken together, the results suggest a significant advance in monitoring capabilities for patients with shunted hydrocephalus, with potential for practical use across a range of settings and circumstances, and additional utility for research purposes in studies of CSF hydrodynamics.
Multimodal Sensing Capabilities for the Detection of Shunt Failure. [2021]Hydrocephalus is a medical condition characterized by the abnormal accumulation of cerebrospinal fluid (CSF) within the cavities of the brain called ventricles. It frequently follows pediatric and adult congenital malformations, stroke, meningitis, aneurysmal rupture, brain tumors, and traumatic brain injury. CSF diversion devices, or shunts, have become the primary therapy for hydrocephalus treatment for nearly 60 years. However, routine treatment complications associated with a shunt device are infection, obstruction, and over drainage. Although some (regrettably, the minority) patients with shunts can go for years without complications, even those lucky few may potentially experience one shunt malfunction; a shunt complication can require emergency intervention. Here, we present a soft, wireless device that monitors distal terminal fluid flow and transmits measurements to a smartphone via a low-power Bluetooth communication when requested. The proposed multimodal sensing device enabled by flow sensors, for measurements of flow rate and electrodes for measurements of resistance in a fluidic chamber, allows precision measurement of CSF flow rate over a long time and under any circumstances caused by unexpected or abnormal events. A universal design compatible with any modern commercial spinal fluid shunt system would enable the widespread use of this technology.
Epidermal electronics for noninvasive, wireless, quantitative assessment of ventricular shunt function in patients with hydrocephalus. [2019]Hydrocephalus is a common and costly neurological condition caused by the overproduction and/or impaired resorption of cerebrospinal fluid (CSF). The current standard of care, ventricular catheters (shunts), is prone to failure, which can result in nonspecific symptoms such as headaches, dizziness, and nausea. Current diagnostic tools for shunt failure such as computed tomography (CT), magnetic resonance imaging (MRI), radionuclide shunt patency studies (RSPSs), and ice pack-mediated thermodilution have disadvantages including high cost, poor accuracy, inconvenience, and safety concerns. Here, we developed and tested a noninvasive, skin-mounted, wearable measurement platform that incorporates arrays of thermal sensors and actuators for precise, continuous, or intermittent measurements of flow through subdermal shunts, without the drawbacks of other methods. Systematic theoretical and experimental benchtop studies demonstrate high performance across a range of practical operating conditions. Advanced electronics designs serve as the basis of a wireless embodiment for continuous monitoring based on rechargeable batteries and data transmission using Bluetooth protocols. Clinical studies involving five patients validate the sensor's ability to detect the presence of CSF flow (P = 0.012) and further distinguish between baseline flow, diminished flow, and distal shunt failure. Last, we demonstrate processing algorithms to translate measured data into quantitative flow rate. The sensor designs, fabrication schemes, wireless architectures, and patient trials reported here represent an advance in hydrocephalus diagnostics with ability to visualize flow in a simple, user-friendly mode, accessible to the physician and patient alike.
Measurement of flow of cerebrospinal fluid in shunts by transcutaneous thermal convection. Technical note. [2007]With the goal of developing a practical method of performing noninvasive measurements of flow in cerebrospinal fluid (CSF) shunts, transcutaneous thermal convection CSF shunt flow measurement was investigated using dimensional analysis, numerical modeling, and bench testing. Using appropriate manufacturing practices and controls, a microcontroller-based device was designed, constructed, and clinically tested. Flow was detected in functioning shunts nine times in 10 attempts. One test failed due to postoperative edema, and subsequent testing was limited to patients who had not undergone shunt surgery within the previous 2 weeks. On the basis of these data and previous reports, 510(k) clearance was granted by the Food and Drug Administration for detection of flow in CSF shunts. Flow in CSF shunts can be detected noninvasively and cost effectively by using a simple thermal convection system. The positive and negative predictive values of the test are equal to or greater than those of brain imaging and radionuclide shunt studies.
Evaluation of the ShuntCheck noninvasive thermal technique for shunt flow detection in hydrocephalic patients. [2010]ShuntCheck (Neuro Diagnostic Devices, Inc., Trevose, Pennsylvania) is a new device designed to detect cerebrospinal fluid (CSF) flow in a shunt by sensing skin temperature downstream from a region of CSF cooled by an ice cube.
A noninvasive approach to quantitative measurement of flow through CSF shunts. Technical note. [2003]A method of measuring flow rate through cerebrospinal fluid (CSF) shunts is reported. It consists of two thermistors in series applied to the skin over the shunt tubing. The thermistors respond by a drop in measured temperature following application of an ice cube placed on the skin overlying the proximal shunt tube. The time required for the thermal response to travel between the two thermistors is related to the velocity of flow through the shunt tubing. Flow rate can then be calculated using the internal diameter of the tubing. A series of animal experiments employing a constant infusion of mock CSF through subcutaneously implanted shunt tubing showed excellent correlation between calculated flow rates and actual infusion rates. The device is noninvasive and easily adapted to use in patients. The measurements are readily repeatable.