Assessment of CSF Shunt Flow With Thermal Measurements

Learn more about:
Related Clinical Trial
EVD Drainage Data and Intracranial Pressure (ICP) Measurements Caregiver Burden and Anxiety in Mothers of Children With Hydrocephalus Comparison of Programmable and Non-programmable CSF Shunts Among Adult Hydrocephalus Patients With Different Etiologies Pilot Study to Evaluate the CereVasc® eShunt® System in the Treatment of Communicating Hydrocephalus Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar Assessment of CSF Shunt Flow With Thermal Measurements B The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus: A Pilot Study Quantitative Pupillometry Pilot Study to Evaluate the CereVasc® eShunt® System US Pilot Study to Evaluate the CereVasc® eShunt® System Prediction Model of Improvement of Disturbance of Consciousness in Patients With Hydrocephalus After Shunt Operation Combined Flow and Pressure Study of Craniospinal Dynamic Assessment of CSF Shunt Flow With Thermal Measurements Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)? Brain Aneurysms: Utility of Cisternal Urokinase Irrigation Three-step Disinfection Reduce the Postoperative Infection Rate of Ventriculoperitoneal Shunt Endoscopic Third Ventriculostomy for Adults: A Prognostic Model for Success The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt) Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ? Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients’ Treatment Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage Bactiseal Catheter Safety Registry in China Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement Hyperfine Portable MRI in Hydrocephalus Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries An Evaluation of a Non-invasive Brain Monitor An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device Assess Specific Kinds of Children Challenges for Neurologic Devices Study A Secondary Study Evaluating Aqueduct’s Smart External Drain (SED) Simulation Efficacy in Neurosurgical Education Intraoral 30% Glucose Effect In Newborns The Prediction of Intracranial Pressure and Clinical Outcome by Transcranial Doppler in Neurocritical Patients Impact of Ventricular Catheter Used With Antimicrobial Agents on Patients With a Ventricular Catheter Subgaleal Drains in Decompressive Craniectomies Role of Proteomics and Metallomics in Cerebral Vasospasm Following Subarachnoid Hemorrhage A Study Evaluate Aqueduct’s Smart External Drain Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH) Optimizing Treatment of Post-hemorrhagic Ventricular Dilation in Preterm Infants Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters Study of Ultrasound of the Eye for Children With Suspected Shunt Failure MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics Tablet-guided Versus Freehand (Tab-Guide) Ventriculostomy : Study Protocol to the Test Accuracy of Ventriculostomy in a Randomized Controlled Trial Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System. Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage Brain Ultrasound in the Weaning of External Ventricular Leads A Study on the Safety of Hakim Programmable Shunt System Thermal Camera Detection of Ventriculoperitoneal Shunt Flow Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique Bench Study of Transcutaneous Hydrocephalic Shunt Flow Sensor Alignment Accuracy and Repeatability NIMIP: Non Invasive Measurement of the Intracranial Pressure Linking Digital Smartphone Behaviour With Brain Function Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains. Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement–Celda Infusion Subprotocol Strata Programmable CSF Shunt Valve Study The CSF Shunt Entry Site Trial Guided Application of Ventricular Catheters Value of MRI CSF Flowmetry in Assessment of Grey Zone Hydrocephalic Patients Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor Comparison of Optic Nerve Sheath Diameter Measured by Ultrasonography Before and After Ventriculoperitoneal Shunt Surgery in Adult Patients With Hydrocephalus CRT ShuntCheck “Fit & Function” Study Monitoring Patient Cerebro-Spinal Fluid Drainage With an Ultrasonic Flow Sensor Cerebrospinal Fluid Proteom in Dependence of Intranasal Breast Milk NIRS Monitoring in Premature Infants Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasound Before and After Drainage of Cerebrospinal Fluid in Patient With Hydrocephalus Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasonography Before and After Drainage of Cerebrospinal Fluid in Pediatric Patient With Hydrocephalus ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients Isoflurane-induced Neuroinflammation in Children With Hydrocephalus Hydrocephalus iPad-App Based Intervention Study Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus A Study Comparing Two Treatments for Infants With Hydrocephalus A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus Efficacy Study of Hydrocephalus Surgery by Methods of Neuroelectrophysiology Study of Choroid Plexus Cauderization in Patients With Hydrocephalus ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus BIS Monitoring of Patients With Hydrocephalus Magnetic Resonance Elastography in Hydrocephalus Noninvasive Intracranial Pressure and Hydrocephalus Patients Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Brief Title

Assessment of CSF Shunt Flow With Thermal Measurements A

Official Title

Assessment Of Flow In Cerebrospinal Fluid Shunts With A Wireless Thermal Anisotropy Measurement Device: Phase A

Brief Summary

      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.
    

Detailed Description

      Patients with an existing implanted ventriculoperitoneal (VP) shunt and who are experiencing
      shunt malfunction symptoms will be recruited by the clinical investigators at each
      investigational site in accordance with the inclusion and exclusion criteria. Assessment of
      shunt flow will be performed non-invasively with the study device; physician and clinical
      staff will be blinded to the device result. Standard-of-care assessment of shunt function
      will be performed and surgical intervention will occur based on the judgement of the treating
      neurosurgeon without the use of study device data. This trial will evaluate the ability of
      the study device to identify shunt malfunctions in need of surgical revision.
    


Study Type

Observational


Primary Outcome

Diagnostic Performance


Condition

Hydrocephalus

Intervention

Thermal Anisotropy Measurement Device

Study Arms / Comparison Groups

 Hydrocephalus Patients
Description:  Hydrocephalus patients with an existing ventriculoperitoneal shunt and symptoms of a shunt malfunction.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

40

Start Date

August 25, 2021

Completion Date

September 15, 2022

Primary Completion Date

September 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Existing ventriculoperitoneal CSF shunt

          -  At least one symptom of shunt malfunction as determined by the investigator, including
             seizure, fever, headache, vision problems, dizziness, disorientation, confusion,
             vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along
             shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of
             sensory or motor function

          -  Suspicion of shunt obstruction warrants the performance of a test for this condition
             in the investigator's judgement

          -  Region of intact skin overlying an unambiguously identifiable chronically indwelling
             ventricular shunt which crosses the clavicle and is appropriate in size for
             application of the study device

          -  Available for follow-up for up to fourteen days

          -  Signed informed consent by patient or a parent, legal guardian, health care agent, or
             legally authorized representative.

          -  Verbal assent by minors four years of age and older who are able to understand the
             study and communicate their decision

        Exclusion Criteria:

          -  Presence of multiple shunts, or presence of more than one distal shunt catheter
             (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected
             obstruction

          -  Use of the study device would interfere with standard patient care, or emergency
             surgery that cannot be delayed

          -  Presence of an interfering open wound or edema over any portion of the shunt

          -  Patient-reported history of adverse skin reactions to adhesives

          -  Investigator judges that the subject is likely to be lost to follow-up due to
             unavailability or clinical outcome being unobtainable

          -  Participation in the study will interfere with, or be detrimental to, administration
             of optimal health-care to the subject

          -  Prior enrollment in this study (multiple enrollments of the same patient are
             disallowed)

          -  Participation in any other investigational procedural, pharmaceutical, and/or device
             study that may influence the collection of valid data under this study
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Sandi Lam, 855-814-3569, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05015751

Organization ID

2020-01


Responsible Party

Sponsor

Study Sponsor

Rhaeos, Inc.


Study Sponsor

Sandi Lam, Principal Investigator, Ann & Robert H Lurie Children's Hospital of Chicago


Verification Date

August 2022