Clinical trials: Cerebrospinal Fluid Shunts
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
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.
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
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, Normal Pressure, Ventriculomegaly, Cerebral
Volumetrics and Proteomics in Shunted Normal Pressure Hydrocephalus
Idiopathic normal pressure hydrocephalus (=iNPH) is a condition with disturbed circulation of cerebrospinal fluid (=CSF) causing symptoms such as balance and gait disorders, urinary incontinence and cognitive impairment in…
- Conditions
- Hydrocephalus, Normal Pressure, Ventriculomegaly, Cerebral, Shunt; Complications, Hydrocephalus Acquired
- Trial name
- LiNPH (NCT04785560)
- Testing
- Initial shunt setting post-operatively of the Certas Plus shunt valve.
- Where
- Sweden
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- University Hospital, Linkoeping
Hydrocephalus
A Study Comparing Two Treatments for Infants With Hydrocephalus
The purpose of this study is to study whether infants with triventricular hydrocephalus (TVH) have a better long-term outcome at 5 years when they are treated with a new procedure, endoscopic third ventriculostomy (ETV), than…
- Trial name
- NCT00652470
- Testing
- Endoscopic Third Ventriculostomy, CSF Shunt Insertion
- Where
- 22 sites in United States, Argentina and 14 more
- Volunteers
- 182 people
- Sponsor
- The Hospital for Sick Children
Hydrocephalus
The CSF Shunt Entry Site Trial
The purpose of the study is to compare the survival time (time to first shunt failure) of ventriculoperitoneal (VP) shunts inserted through an anterior entry site with those inserted through a posterior entry site in children.
- Trial name
- NCT02425761
- Testing
- Ventriculoperitoneal shunt insertion surgery
- Where
- 14 sites in United States, Canada
- Volunteers
- 448 people
- Sponsor
- Baylor College of Medicine
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.
Cerebrospinal Fluid Shunts, Ventriculoperitoneal Shunt
Ceftaroline Diffusion Into Cerebrospinal Fluid of Children
Ceftaroline fosamil is an intravenous (IV) drug that belongs to a group of antibiotics called cephalosporins . Antibiotics are drugs used to treat infections.
- Trial name
- NCT02600793
- Testing
- Ceftaroline
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Basim Asmar
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
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, Ventriculoperitoneal Shunt Infection
Efficacy and Cost-Effectiveness of Topical Vancomycin Powder in Preventing Pediatric Ventriculoperitoneal Shunt Infections Across Different Etiologies
Objectives Primary: To measure the reduction in VP shunt infection rates using topical vancomycin powder. Secondary: To compare efficacy across different Etiological Strata (Congenital, Post-hemorrhagic, post-inflammatory).
- Conditions
- Hydrocephalus, Ventriculoperitoneal Shunt Infection, Surgical Site Infection (SSI), Cerebrospinal Fluid Shunt Infection
- Trial name
- NCT07547826
- Testing
- Topical Vancomycin Powder, Standard Perioperative Care
- Where
- Egypt
- Volunteers
- 164 people
- Sponsor
- Assiut University
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
Strata Programmable CSF Shunt Valve Study
The treatment of hydrocephalus is the most time consuming, and arguably the most important role of the pediatric neurosurgical service at most children's' hospitals.
- Trial name
- NCT02737163
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- Johns Hopkins All Children's Hospital
Hydrocephalus
A Prospective Study Comparing CSF Shunt Flow Between "Virtual Off" and "Flow Permissive" Shunt Valve Settings Using a Wireless, Noninvasive Shunt Flow 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
- NCT07815314
- Testing
- Rhaeos Shunt Monitoring System (RSMS), ShuntCheck III
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Rhaeos, 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.
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.
Normal Pressure Hydrocephalus
Effect of Depletive Lumbar Puncture on Lower Urinary Tract Dysfunction in iNPH
Lower urinary tract dysfunction in normal pressure hydrocephalus has received little attention from the scientific community. Urinary symptoms in normal pressure hydrocephalus are mainly represented by overactive bladder, which…
- Trial name
- PLHPN (NCT03877107)
- Testing
- Urinary symptoms profile questionnaire, Micturition calendar
- Where
- 2 sites in France
- Volunteers
- 100 people
- Sponsor
- EssaiClinique_PL-HPN
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
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.