Clinical trials: Cerebrospinal Fluid Shunts
Hydrocephalus
Assessment of CSF Shunt Flow and Headaches With a Thermal Measurement Device
This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during headache and non-headache periods.
- Trial name
- NCT06996600
- Testing
- wireless thermal anisotropy measurement device
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Rhaeos, Inc.
Hydrocephalus
Measurements of CSF Shunts and Off-Shunt Locations With Wireless Thermal Anisotropy Measurement Devices
This study collects data using non-invasive devices for assessing CSF shunt flow using thermal anisotropy measurements in a prospective study setting.
- Trial name
- NCT06513572
- Testing
- FlowSense
- Where
- 8 sites in United States
- Volunteers
- 10 people
- Sponsor
- Rhaeos, Inc.
CSF Flow Through the Shunt of a Hydrocephalus Patient
Physician Preference Study of ShuntCheck - Madsen
ShuntCheck can be used to detect CSF flow in asymptomatic hydrocephalus patients and can be used to detect no-flow in symptomatic patients with shunt obstruction.
- Trial name
- NCT00583336
- Testing
- ShuntCheck
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- NeuroDx Development
Hydrocephalus
Monitoring Patient Cerebro-Spinal Fluid Drainage With an Ultrasonic Flow Sensor
The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in hydrocephalic shunts. The ultrasonic sensor will measure cerebro-spinal fluid drainage in hydrocephalus patients with external…
- Trial name
- NCT00652197
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Transonic Systems Inc.
Hydrocephalus
Longitudinal Measurements of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device
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.
- Trial name
- NCT06086561
- Testing
- Thermal Anisotropy Measurement Device
- Where
- 4 sites in United States
- Volunteers
- 130 people
- Sponsor
- Rhaeos, Inc.
Hydrocephalus
Assessment of Flow in Cerebrospinal Fluid Shunts With a Second Generation Wireless Thermal Anisotropy Measurement Device
This study evaluates the performance of a thermal anisotropy measurement device for non-invasively assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction who require shunt revision…
- Trial name
- NCT06409286
- Testing
- Thermal Anisotropy Measurement Device
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Rhaeos, Inc.
Hydrocephalus
Functional and Non-Functional CSF Shunt Flow Measured With a Second-Generation Wireless Thermal Device
This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of known non-functional and functional implanted shunts will assess the diagnostic…
- Trial name
- NCT06506045
- Testing
- FlowSense
- Where
- 8 sites in United States
- Volunteers
- 10 people
- Sponsor
- Rhaeos, Inc.
Hydrocephalus
Assessment of CSF Shunt Flow With Thermal Measurements A
This study evaluates the performance of a non-invasive thermal measurement device for assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device.
- Trial name
- NCT05015751
- Testing
- Thermal Anisotropy Measurement Device
- Where
- 4 sites in United States
- Volunteers
- 44 people
- Sponsor
- Rhaeos, Inc.
Hydrocephalus
A Prospective Study Comparing CSF Shunt Flow Between "Virtual Off" and "Flow Permissive" Shunt Valve Settings Using a Wireless, Noninvasive Shunt Flow Sensor
Hydrocephalus is commonly treated with a cerebrospinal fluid (CSF) shunt, a device that drains excess fluid from the brain. However, shunts can stop working over time, and determining whether fluid is flowing through a shunt can…
- Trial name
- NCT07815314
- Testing
- Rhaeos Shunt Monitoring System (RSMS), ShuntCheck III
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Rhaeos, Inc.
Hydrocephalus
Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device
This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during activities of daily living and sleep
- Trial name
- NCT07050628
- Testing
- wireless thermal anisotropy measurement device
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- Rhaeos, Inc.
Hydrocephalus
Formative Usability Assessment of Wireless Thermal Anisotropy Devices
Measurements of shunt flow will be performed non-invasively. This study will generate usability data via observed tasks and comprehension questions to enable future device design improvements.
- Trial name
- NCT06040697
- Testing
- Thermal Anisotropy
- Where
- United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Rhaeos, Inc.
Hydrocephalus
Assessment of CSF Shunt Flow With Thermal Measurements B
This study evaluates the performance of a non-invasive thermal measurement device for assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device.
- Trial name
- STEALTH (NCT05432986)
- Testing
- Thermal Anisotropy Measurement Device
- Where
- 10 sites in United States
- Volunteers
- 141 people
- Sponsor
- Rhaeos, Inc.
Hydrocephalus
Study of Shunt Flow Under Different Valve Settings Using a Wireless Sensor
Hydrocephalus is commonly treated with a cerebrospinal fluid (CSF) shunt, a device that drains excess fluid from the brain. However, shunts can stop working over time, and determining whether fluid is flowing through a shunt can…
- Trial name
- NCT07679035
- Testing
- Rhaeos Shunt Monitoring System (RSMS), ShuntCheck III
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Rhaeos, Inc.
Hydrocephalus
Assessment of CSF Shunt Flow in an Outpatient Setting with a Thermal Measurement Device
This study collects exploratory data using a non-invasive device for assessing CSF shunt flow using thermal anisotropy measurements.
- Trial name
- NCT06753929
- Testing
- wireless wearable thermal anisotropy measurement device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Rhaeos, Inc.
Hydrocephalus
Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device in Asymptomatic Patients
This study evaluates the performance of the study device, FlowSense®, a sensor for non-invasively assessing cerebrospinal fluid (CSF) shunt flow.
- Trial name
- NCT06410885
- Testing
- Thermal Anisotropy Measurement Device
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Rhaeos, Inc.
Hydrocephalus
Bactiseal Catheter Safety Registry Study
Research Purpose: This study aims to continuously evaluate the safety of subjects implanted with a catheter (trade name: Bactiseal) produced by Integra LifeSciences Production Corporation.
- Trial name
- NCT06276543
- Testing
- antibiotic-impregnated catheter
- Where
- 8 sites in China
- Volunteers
- 200 people
- Sponsor
- Integra LifeSciences Corporation
Hydrocephalus
Flow Measurements in Functional CSF Shunts and Off-Shunt Locations with a Second-Generation Thermal Device
This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic…
- Trial name
- NCT06524492
- Testing
- FlowSense
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- Rhaeos, Inc.
Hydrocephalus
Flow Detection in Open and Closed Shunt Valve Periods
This study is evaluating a new, noninvasive device designed to detect whether cerebrospinal fluid (CSF) is flowing through a surgically implanted shunt.
- Trial name
- NCT07478926
- Testing
- Rhaeos Shunt Monitoring System
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Rhaeos, Inc.