Clinical trials: Cerebrospinal Fluid Shunts
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
Normal Pressure Hydrocephalus
Predictive Value of Flow MRI in Normal Pressure Hydrocephalus Surgery
The idea is to assess the predictive value of flow magnetic resonance imaging (flow MRI) for patient suffering normal pressure hydrocephalus (NPH) planned for surgery.
- Trial name
- NCT01815775
- Testing
- clinical and imaging examinations
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
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, Shunt Malfunction
Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement--Celda Infusion Subprotocol
This research is being done to determine the accuracy of two noninvasive methods of measuring the pressure of the spinal fluid, also known as intracranial pressure (ICP).
- Trial name
- NCT01976559
- Testing
- Tympanic Membrane Displacement (TMD), DPOAE
- Where
- Sweden
- Volunteers
- 15 people
- Sponsor
- LifeBridge Health
Normal Pressure Hydrocephalus, Sleep Apnea
Normal Pressure Hydrocephalus and Sleep Apnea
Normal-pressure hydrocephalus is associated with increases in the intracranial pressure during the night sleep. Sleep apnea also increases the intracranial pressure during the apneic spells.
- Conditions
- Normal Pressure Hydrocephalus, Sleep Apnea, Cerebrospinal Fluid Shunt Occlusion
- Trial name
- NPH/OSA (NCT04471740)
- Testing
- CSF shunt diversion
- Where
- Spain
- Volunteers
- 30 people
- Sponsor
- University of Valencia
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.
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
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.
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
Beta-amiloid and Phospho-tau Proteins in CSF, Ventricular Size After CSF Shunt
CSF Protein Markers as Prognostic Indicators of the Response to CSF Shunt in Normotensive Hydrocephalus
In all published series of adult chronic hydrocephalus, there is a percentage between twenty and twenty-five percent of patients who present poor results after implantation of a cerebrospinal fluid shunt,1-11 usually…
- Conditions
- Beta-amiloid and Phospho-tau Proteins in CSF, Ventricular Size After CSF Shunt, Cognitive Impairment and CSF Shunt, Motor Impairment Evolution After CSF Shunt
- Trial name
- NCT05915000
- Testing
- Lumbar CSF protein marker determination
- Where
- 2 sites in Spain
- Volunteers
- 150 people
- Sponsor
- University of Valencia
Pseudotumor Cerebri, Cerebrospinal Fluid
Stenting Versus Neurosurgical Treatment of Idiopathic Intracranial Hypertension.
Idiopathic intracranial hypertension (HTICi) is a pathology, affecting young adults with a predominance of women, due to an increase in intracranial pressure, which may be associated with stenosis of the cerebral venous sinuses…
- Conditions
- Pseudotumor Cerebri, Cerebrospinal Fluid, Transverse Sinuses
- Trial name
- HYDROPTIC (NCT05050864)
- Testing
- venous sinus stenting, Neurosurgical internal ventricular shunt
- Where
- France
- Volunteers
- 276 people
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
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.
Cerebrospinal Fluid Shunts
Bedside Ultrasound to Measure Optic Nerve Sheath Diameter in Pediatric CSF Shunts
Bedside ultrasound in the emergency department is useful for quick assessments of patients. One growing use is to measure the optic nerve sheath diameter of patients for whom increased pressure in the head is a concern.
- Trial name
- NCT02776085
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences