Clinical trials: Hydrocephalus.
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.
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
CNS Disease
Blood-Brain Barrier Penetration of Therapeutic Agents in Human
This is a phase 1, open-label, non-randomized, exploratory, repeated dose PK study performed at a single centre. Up to 6 evaluable subjects are planned. The subjects will receive p.o. doses of ODM-104 for 5-7 days.
- Trial name
- BRIAN (NCT04571996)
- Testing
- ODM-104, Paracetamol
- Where
- Finland
- Volunteers
- 4 people
- Sponsor
- Orion Corporation, Orion Pharma
Intracranial Pressure, Intracranial Pressure Changes
CoMind Early Feasibility Study
The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around…
- Conditions
- Intracranial Pressure, Intracranial Pressure Changes, Traumatic Brain Injury, Intracerebral Hemorrhage
- Trial name
- CoMind EFS (NCT06368648)
- Where
- 17 sites in United States
- Volunteers
- 581 people
- Sponsor
- CoMind Technologies Limited
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.
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
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
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
Guided Application of Ventricular Catheters
Failure of ventricular catheters remains a significant problem in patients with hydrocephalus. The purpose of this study is to determine whether the use of a simple instrument assisted by a smart phone application software can…
- Trial name
- GAVCA (NCT01811589)
- Testing
- Thomale-Guide, Free-hand
- Where
- 9 sites in Germany
- Volunteers
- 144 people
- Sponsor
- Aesculap AG
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, 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
Idiopathic Normal Pressure Hydrocephalus (iNPH)
The Pilot Study of Medical Device-Neuclare for Patients With Idiopathic Normal Pressure Hydrocephalus (iNPH)
This clinical trial aims to explore the effectiveness and safety of gait improvemen of Neuclare, a science medical device, for patients with Idiopathic Normal Pressure Hydrocephalus (iNPH) Through methods such as Timed Up \& Go…
- Trial name
- NCT06478979
- Testing
- Neuclare
- Where
- South Korea
- Volunteers
- 20 people
- Sponsor
- Deepsonbio
Hydrocephalus, Hydrocephalus in Children
Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
- Conditions
- Hydrocephalus, Hydrocephalus in Children, NPH (Normal Pressure Hydrocephalus), IIH - Idiopathic Intracranial Hypertension
- Trial name
- NCT05397106
- Testing
- CODMAN CERTAS Plus Programmable Valve
- Where
- 9 sites in Belgium, Germany and 2 more
- Volunteers
- 160 people
- Sponsor
- Integra LifeSciences Corporation
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.
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
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
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
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
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
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.