Clinical trials: Hydrocephalus
Normal Pressure Hydrocephalus
ShuntCheck Accuracy in Detecting Shunt Obstruction Normal Pressure Hydrocephalus (NPH) Patients
The purpose of this study is to examine the role of ShuntCheck and MR Imaging in evaluating the presence or absence of Shunt Obstruction in the patients of Hydrocephalus or Idiopathic Intracranial Hypertension (IIH) undergoing…
- Trial name
- NCT00793416
- Testing
- Shunt flow detection
- Where
- United States
- Sponsor
- NeuroDx Development
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
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
Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus
To determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical and histochemistry estimates of amyloid levels in frontal lobe biopsy samples…
- Trial name
- NCT01092546
- Testing
- [18F]Flutemetamol
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- GE Healthcare
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
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.
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
Blocked Ventricular Shunts
Multi-Center Study of ShuntCheck
Multi-Center Study of ShuntCheck
- Trial name
- NCT00788385
- Testing
- ShuntCheck test
- Sponsor
- NeuroDx Development
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
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
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 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
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 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
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
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
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.
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 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, 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