Clinical trials: Cerebrospinal Fluid Shunts, open to volunteers
Brain Pulsatility, Idiopathic Normal Pressure Hydrocephalus (INPH)
Transcranial Ultrasound Assessment of Cerebral Pulsatility in Shunt Decision-making for Suspected Idiopathic Normal Pressure Hydrocephalus: a Prospective Cohort Study
This will be a single-center, prospective, analytical cohort study. All included patients will undergo transcranial ultrasound (TPI) with measurement of cerebral pulsatility parameters prior to subtractive lumbar puncture during…
- Trial name
- HYDROPULSE (NCT07285928)
- Where
- France
- Volunteers
- 110 people
- Sponsor
- University Hospital, Tours
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.
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
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, 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
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.
Hydrocephaly, CSF Shunts
Cefazolin Antibiotic Prophylaxis in Ventricular Shunt Surgery: Determination of Cerebrospinal Fluid Concentration During Valve Implantation
The objective is to determine the concentration of cefazolin in the cerebrospinal fluid after a recommended antiobiotic prophylaxis by 2g of cefazolin.
- Conditions
- Hydrocephaly, CSF Shunts, Antibiotic Prophylaxis
- Trial name
- CC -PIV (NCT07067736)
- Testing
- Cefazolin antibiotic prophylaxis
- Where
- France
- Volunteers
- 15 people
- Sponsor
- University Hospital, Strasbourg, France
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
Hydrocephalus
Flow Detection in Open and Closed Shunt Valve Periods
This study is evaluating a new, noninvasive device designed to detect whether cerebrospinal fluid (CSF) is flowing through a surgically implanted shunt.
- Trial name
- NCT07478926
- Testing
- Rhaeos Shunt Monitoring System
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Rhaeos, Inc.
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 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.
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
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
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.
Idiopathic Normal Pressure Hydrocephalus
Multi-omics Research of Idopathic Normal Pressure Hydrocephalus (iNPH)
The research is designed to study the prognostic factors of ventriculoperitoneal (VP) shunt for iNPH by multi-omics research
- Trial name
- NCT04998175
- Testing
- ventriculo-peritoneal shunt
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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.