Clinical trials: Hydrocephalus.
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
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.
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
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
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
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, 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
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, 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
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.
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
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, Normal Pressure, Hydrocephalus
Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
The eShunt System includes proprietary delivery componentry and the eShunt Implant, a permanent implant deployed in a minimally invasive, neurointerventional procedure.
- Trial name
- NCT05250505
- Testing
- eShunt Implant
- Where
- Argentina
- Volunteers
- 30 people
- Sponsor
- CereVasc 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.
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
Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus (NPH) Registry
The overall aim of the registry is to develop a longitudinal, observational database that is focused on adult patients with Normal Pressure Hydrocephalus (NPH) that can be used as a source of clinical information for individual…
- Trial name
- NCT00233701
- Where
- 28 sites in United States
- Volunteers
- 343 people
- Sponsor
- Codman & Shurtleff
Hydrocephalus
A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus
The purpose of this Registry is to compare shunt/catheter-related infection rates among various shunt systems when used according to hospital standard of care to treat hydrocephalus.
- Trial name
- NCT00280904
- Testing
- Shunt catheter
- Where
- 8 sites in United States, Canada and 4 more
- Volunteers
- 433 people
- Sponsor
- Codman & Shurtleff
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
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
Bench Study of Transcutaneous Hydrocephalic Shunt Flow Sensor Alignment Accuracy and Repeatability
The study hypothesis is that nurses and doctors can use a transcutaneously powered ultrasonic flow sensor to make repeatable and accurate hydrocephalic shunt flow measurements.
- Trial name
- NCT00651950
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Transonic Systems Inc.