Clinical trials: Hydrocephalus
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
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
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
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
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, Hydrocephalus, Communicating
Pilot Study to Evaluate the CereVasc® EShunt® System in the Treatment of Communicating Hydrocephalus
The purpose of this study will be to evaluate a novel, minimally invasive method of treating hydrocephalus in adults. The eShunt® System includes a proprietary eShunt® Delivery System and the eShunt® Implant, a permanent implant…
- Trial name
- NCT05501002
- Testing
- eShunt® Implant
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- CereVasc Inc
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
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
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
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
Brain Injuries, Subarachnoid Hemorrhage
An Evaluation of a Non-invasive Brain Monitor
HS-1000 device, a proprietary new non-invasive brain monitor, is expected to safely and accurately monitor physiological signs of the brain with minimal discomfort to patients, providing information about normal or abnormal…
- Conditions
- Brain Injuries, Subarachnoid Hemorrhage, Vasospasm, Intracranial, Hydrocephalus
- Trial name
- NCT02775136
- Testing
- HS-1000 recording
- Where
- 4 sites in Germany
- Volunteers
- 160 people
- Sponsor
- HeadSense Medical
Hydrocephalus, Hydrocephalus in Children
A Secondary Study Evaluating Aqueduct's Smart External Drain (SED)
Aqueduct's Smart External Drain (SED) will be compared to the current gold standard for temporary CSF management in a hospital setting.
- Conditions
- Hydrocephalus, Hydrocephalus in Children, Tumor, Brain, Subarachnoid Hemorrhage
- Trial name
- NCT03471702
- Testing
- Smart External Drain - SED
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Aqueduct Critical Care
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, Hydrocephalus in Children
A Study Evaluate Aqueduct's Smart External Drain
To evaluate the performance characteristics of the Smart External Drain (SED) compared with standard EVD drains in the hospital setting, specifically: Number, type and duration of staff interactions.
- Conditions
- Hydrocephalus, Hydrocephalus in Children, Tumor, Brain
- Trial name
- SED (NCT03113799)
- Testing
- Smart External Drain - SED
- Where
- 2 sites in United States
- Volunteers
- 56 people
- Sponsor
- Aqueduct Critical Care
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 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
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, 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
ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients
The purpose of this study is to compare the accuracy of ShuntCheck (SC) and ShuntCheck plus Micro-Pumper (SC+MP) to radionuclide shunt patency testing (SPS) in evaluating shunt function in patients with adult hydrocephalus (AH)…
- Trial name
- SCNPH (NCT01323764)
- Testing
- ShuntCheck test
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- NeuroDx Development
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