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Clinical Trials in the USA / NCT06498960
Active, not recruiting Not applicable

Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus

NCT06498960 · tracked via the Priya Life Science USA tracker
Sponsor
CereVasc Inc
Phase
Not applicable
Started
2024-11-26
Last updated
2026-06-25

Condition(s) studied

Normal Pressure Hydrocephalus

Investigational drug(s) / intervention(s)

CereVasc eShunt SystemVP Shunt

CereVasc eShunt System: The eShunt System consists of the following components: * eShunt Implant * eShunt Delivery Catheter and Transfer Tool * eShunt Anchor

VP Shunt: Control arm - VP shunt

Study summary

Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.

Eligibility

Sex
ALL
Min age
60 Years
Max age
Healthy volunteers
No
Inclusion Criteria: Each subject must meet the following criteria: 1. Patients ≥60 years old on the day of study informed consent 2. Patient or legally authorized representative is able and willing to provide written informed consent 3. History or evidence of gait impairment with a duration ≥3 months 4. Clinical presentation consistent with NPH including two or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with all of the following: 1. Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index \>0.3) and the absence of severe hippocampal atrophy, 2. Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%, 3. CSF opening pressure ≥8 cmH2O, 4. Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12 5. Patient is willing and able to attend all scheduled visits and comply with study procedures. 6. Confirmation of anatomy suitable for the eShunt procedure, as determined by evaluation of pre-procedure imaging (CT and MRI) and approved by an independent anatomical screening committee. Exclusion Criteria: Each subject may not: 1. Be unable to walk 10 meters (33 feet) with or without an assistive device 2. Be diagnosed with obstructive hydrocephalus 3. Have an active systemic infection or infection detected in CSF 4. Have had prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus 5. Demonstrate hypersensitivity or contraindication to heparin or radiographic contrast agents against which the subject cannot be adequately pre-medicated, desensitized or where no alternative is available 6. Have occlusion or stenosis of the internal jugular vein which would prohibit access to the IPS 7. Present with venous distension in the neck on physical exam 8. Have medical conditions associated with prolonged elevation of jugular venous pressure, including jugular vein stenosis or stricture, right sided heart failure, cirrhosis of the liver, arteriovenous fistulas in the arm for dialysis purposes, or an arterial venous fistula or malformation in the neck or brain 9. Have history of bleeding diatheses, coagulopathy or refuse to consent for blood transfusion in cases of emergency 10. Have had an ischemic stroke or transient ischemic attack within 180 days of eShunt procedure 11. Have documented evidence of a deep vein thrombosis superior to the popliteal vein 12. Have intrinsic blood clotting disorder 13. Have medical conditions requiring anticoagulation which is unable to be managed to allow for surgical procedure 14. Have presence of a posterior fossa tumor or mass 15. Have a life expectancy \<1 year 16. Be currently participating in another interventional (drug, device, etc.) research project that may confound the results of this study. 17. Have established diagnosis of neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, or Lewy body dementia 18. Be diagnosed with schizophrenia or any psychiatric diagnosis (including depression) that may complicate outcome evaluation 19. Need an intracranial neurosurgical procedure within 180 days of study index procedure 20. Be unwilling or unable to comply with follow-up requirements 21. Have mRS of 0, 5, or 6

Primary outcome measure(s)

Trial sites (32)

FacilityCityRegionStatus
University of Southern California Los Angeles California
Yale University New Haven Connecticut
Baptist Medical Center - Jacksonville Jacksonville Florida
University of South Florida Tampa Florida
Northwestern University Chicago Illinois
Advocate Lutheran General Hospital Park Ridge Illinois
Indiana University Indianapolis Indiana
University of Kansas Medical Center Kansas City Kansas
University of Kentucky Research Foundation Lexington Kentucky
Massachusetts General Hospital Boston Massachusetts
Brigham and Women's Hospital Boston Massachusetts
Beth Israel Deaconess Medical Center Boston Massachusetts
Henry Ford Health West Bloomfield Michigan
Cooper Neurological Institute Camden New Jersey
Albany Medical Center Albany New York
University at Buffalo Neurosurgery Buffalo New York
Northwell Health Manhasset New York
NYU Langone Health New York New York
Icahn School of Medicine at Mount Sinai New York New York
Weill Cornell Medicine New York New York
Lenox Hill Hospital New York New York
University of Rochester Medical Center Rochester New York
Montefiore Medical Center The Bronx New York
Cleveland Clinic Cleveland Ohio
Milton S. Hershey Medical Center Hershey Pennsylvania
Thomas Jefferson University Philadelphia Pennsylvania
Rhode Island Hospital Providence Rhode Island
University of Texas Southwestern Medical Center Dallas Texas
Virginia Commonwealth University Richmond Virginia
Clinica La Sagrada Familia Buenos Aires Argentina
University of Calgary - Foothills Medical Centre Calgary Alberta
St. Michael's Hospital Toronto Ontario

More CereVasc Inc trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06498960 on ClinicalTrials.gov ↗ ← All trials in the USA