Clinical trials: Hydrocephaly
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, Normal Pressure, Hydrocephalus
US Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
The eShunt® System is a minimally invasive method of treating communicating hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the eShunt Implant, a permanent implant deployed in a minimally…
- Trial name
- NCT05232838
- Testing
- eShunt Implant
- Where
- 11 sites in United States
- Volunteers
- 50 people
- Sponsor
- CereVasc Inc
Hydrocephalus, Normal Pressure Hydrocephalus
A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System.
The purpose of this study is to determine the agreement rate between the CODMAN Valve Position Verification (VPV) adjustment outcome (reprogramming) and X-ray verification in order to support an alternative to X-ray confirmation…
- Trial name
- NCT00196196
- Testing
- Codman VPV System
- Where
- 8 sites in United States
- Volunteers
- 274 people
- Sponsor
- Codman & Shurtleff
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 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.
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
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
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 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 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
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
Meningioma, Tumor, Brain
MiDura-Study (Neuro-Patch in Duraplasty)
The aim of this study is to collect systematically and proactively data regarding the performance of Neuro-Patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer
- Conditions
- Meningioma, Tumor, Brain, Chiari Malformation, Vascular Malformation
- Trial name
- MiDura (NCT04189172)
- Where
- 4 sites in France, Germany
- Volunteers
- 328 people
- Sponsor
- Aesculap AG
Normal Pressure Hydrocephalus
PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
This study will determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples previously obtained…
- Trial name
- NCT01053312
- Testing
- [18F] Flutemetamol
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- GE Healthcare
Hydrocephalus
CRT ShuntCheck "Fit & Function" Study
An exploratory "Fit \& Function" study of Continuous Real Time (CRT) ShuntCheck, a non-invasive method for monitoring changes in cerebrospinal fluid (CSF) shunt flow in hydrocephalus patients.
- Trial name
- NCT02067364
- Testing
- Fit & Function test
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- NeuroDx Development
Hydrocephalus
Bactiseal Catheter Safety Registry in China
Research Purpose: This study aimed to continue to evaluate safety information from subjects implanted with a catheter (trade name: Bactiseal) produced by Codman \& Shurtleff, Inc. of the United States.
- Trial name
- NCT04496414
- Testing
- Bactiseal Catheter
- Where
- 3 sites in China
- Volunteers
- 50 people
- Sponsor
- Integra LifeSciences Corporation
Normal Pressure Hydrocephalus
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.
- Trial name
- STRIDE (NCT06498960)
- Testing
- CereVasc eShunt System, VP Shunt
- Where
- 32 sites in United States, Argentina and 1 more
- Volunteers
- 230 people
- Sponsor
- CereVasc Inc
Hydrocephalus, NPH (Normal Pressure Hydrocephalus)
CERTAS Programmable Valve Registry
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
- Conditions
- Hydrocephalus, NPH (Normal Pressure Hydrocephalus), IIH - Idiopathic Intracranial Hypertension
- Trial name
- CERTAS (NCT04207229)
- Testing
- CODMAN CERTAS Programmable Valves
- Where
- 8 sites in Germany, Netherlands
- Volunteers
- 35 people
- Sponsor
- Integra LifeSciences Corporation
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.
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