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RECRUITING
NCT06498960
NA

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

Sponsor: CereVasc Inc

View on ClinicalTrials.gov

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

Interventions

DEVICE

CereVasc eShunt System

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

DEVICE

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