Clinical trials: Hydrocephalus.
- Condition Hydrocephalus.
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
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.
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
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
A Study on the Safety of Hakim Programmable Shunt System
This study aimed to collect safety information from subjects implanted with a shunt system (trade name: Hakim Shunt Programmable System) produced by Codman \& Shurtleff, Inc. of the United States.
- Trial name
- NCT04285489
- Testing
- Hakim Shunt Programmable System
- Where
- 5 sites in China
- Volunteers
- 130 people
- Sponsor
- Integra LifeSciences Corporation
Hydrocephalus
Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
The SAPPHYRE study is an ambispective (retrospective and prospective) PMCF study with the objective to evaluate the safety and performance of the Polaris® 24 adjustable valve system in the treatment of 126 patients with…
- Trial name
- SAPPHYRE (NCT04746625)
- Where
- 2 sites in France
- Volunteers
- 126 people
- Sponsor
- Sophysa
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, Nervous System Diseases
Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains.
The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in hydrocephalic shunts. The ultrasonic sensor will measure cerebrospinal fluid drainage in hydrocephalus patients with external ventriculostomies…
- Conditions
- Hydrocephalus, Nervous System Diseases, Infant, Newborn Diseases
- Trial name
- NCT01108965
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Transonic Systems Inc.
Hydrocephalus
Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor
The study hypothesis is that a transit-time ultrasonic sensor can help doctors diagnose a malfunctioning shunt valve. The study will simulate an implanted shunt flow monitoring system by placing the flow sensor and a programmable…
- Trial name
- NCT00652249
- Where
- United States
- Sponsor
- Transonic Systems 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
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 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 Shunt (proGAV) Requiring Adjustment
X-Ray Verified Accuracy of the proGAV Verification Instrument
This study is to verify the use of a hand held tool to verify the new setting of a hydrocephalus shunt (proGAV). This tool would be used in place of an Xray of the patient's head, which is how settings are verified currently.
- Trial name
- X-AMIN (NCT01885468)
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Aesculap, Inc.
Head Injury
Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial…
- Trial name
- NCT01824589
- Testing
- -7 cm H2O ITPR, -12cm H2O ITPR
- Volunteers
- 1 people
- Sponsor
- Advanced Circulatory Systems
Suspected CSF Shunt Obstruction
ShuntCheck-Micro-Pumper Pediatric Clinical Outcomes Study
Primary objective is to demonstrate that data collected from ShuntCheck-Micro-Pumper (SCMP) testing results can be used in conjunction with imaging to diagnose shunt patency or obstruction in pediatric/adolescent subjects…
- Trial name
- NCT01881711
- Testing
- ShuntCheck-Micro-Pumper (SCMP), Imaging
- Where
- 11 sites in United States
- Volunteers
- 400 people
- Sponsor
- NeuroDx Development
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
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.
Hydrocephaly
Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters
The objective of this pilot study is to perform a set of pressure and flow rate measurements in order to quantitatively characterize safe irrigation or "flushing" of a ventricular shunt catheter, a routine maneuver performed by a…
- Trial name
- NCT02651337
- Testing
- Cerebrospinal Fluid (CSF) Drainage
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Alcyone Therapeutics, 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
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.
Intracranial Hypertension, Brain Injuries
An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device
Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks. HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's head.
- Conditions
- Intracranial Hypertension, Brain Injuries, Stroke, Hydrocephalus
- Trial name
- NCT02773888
- Testing
- HS-1000
- Where
- 5 sites in Japan
- Volunteers
- 80 people
- Sponsor
- HeadSense Medical