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RecruitingNot ApplicableNCT06498960

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

Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus

Sponsor

CereVasc Inc

Enrollment

230 participants

Start Date

Nov 26, 2024

Study Type

INTERVENTIONAL

Conditions

Normal Pressure Hydrocephalus

Summary

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

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called CereVasc eShunt System and a medical device called VP Shunt for people with normal pressure hydrocephalus. The study is currently recruiting participants at 31 locations. People eligible for this study include aged 60 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECereVasc eShunt System

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

DEVICEVP Shunt

Control arm - VP shunt

Locations(31)

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

Weill Cornell Medicine

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

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NCT06498960

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