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Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Sponsor: CereVasc Inc
Summary
Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.
Official title: Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus
Key Details
Gender
All
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
230
Start Date
2024-11-26
Completion Date
2031-06
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
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
Locations (30)
University of Southern California
Los Angeles, California, United States
Yale University
New Haven, Connecticut, United States
Baptist Medical Center - Jacksonville
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky Research Foundation
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Health
West Bloomfield, Michigan, United States
Cooper Neurological Institute
Camden, New Jersey, United States
Albany Medical Center
Albany, New York, United States
University at Buffalo Neurosurgery
Buffalo, New York, United States
Northwell Health
Manhasset, New York, United States
NYU Langone Health
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Clinica La Sagrada Familia
Buenos Aires, Argentina
University of Calgary - Foothills Medical Centre
Calgary, Alberta, Canada
St. Michael's Hospital
Toronto, Ontario, Canada