Clinical trials: Hydrocephaly
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
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.
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
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
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
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, 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
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
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
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.
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
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, 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
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.
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
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
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
Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
The SAPPHYRE study is an ambispective (retrospective and prospective) PMCF study with the objective to evaluate the safety and performance of the Polaris® 24 adjustable valve system in the treatment of 126 patients with…
- Trial name
- SAPPHYRE (NCT04746625)
- Where
- 2 sites in France
- Volunteers
- 126 people
- Sponsor
- Sophysa
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
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.