Normal Pressure Hydrocephalus Clinical Trials

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

Status: Active_not_recruiting
Location: See all (32) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

∙ Each subject must meet the following criteria:

• Patients ≥60 years old on the day of study informed consent

• Patient or legally authorized representative is able and willing to provide written informed consent

• History or evidence of gait impairment with a duration ≥3 months

• 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:

‣ Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index \>0.3) and the absence of severe hippocampal atrophy,

⁃ Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%,

⁃ CSF opening pressure ≥8 cmH2O,

⁃ Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12

• Patient is willing and able to attend all scheduled visits and comply with study procedures.

• 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.

Locations
United States
California
University of Southern California
Los Angeles
Connecticut
Yale University
New Haven
Florida
Baptist Medical Center - Jacksonville
Jacksonville
University of South Florida
Tampa
Illinois
Northwestern University
Chicago
Advocate Lutheran General Hospital
Park Ridge
Indiana
Indiana University
Indianapolis
Kansas
University of Kansas Medical Center
Kansas City
Kentucky
University of Kentucky Research Foundation
Lexington
Massachusetts
Beth Israel Deaconess Medical Center
Boston
Brigham and Women's Hospital
Boston
Massachusetts General Hospital
Boston
Michigan
Henry Ford Health
West Bloomfield
New Jersey
Cooper Neurological Institute
Camden
New York
Albany Medical Center
Albany
University at Buffalo Neurosurgery
Buffalo
Northwell Health
Manhasset
Icahn School of Medicine at Mount Sinai
New York
Lenox Hill Hospital
New York
NYU Langone Health
New York
Weill Cornell Medicine
New York
University of Rochester Medical Center
Rochester
Montefiore Medical Center
The Bronx
Ohio
Cleveland Clinic
Cleveland
Pennsylvania
Milton S. Hershey Medical Center
Hershey
Thomas Jefferson University
Philadelphia
Rhode Island
Rhode Island Hospital
Providence
Texas
University of Texas Southwestern Medical Center
Dallas
Virginia
Virginia Commonwealth University
Richmond
Other Locations
Argentina
Clinica La Sagrada Familia
Buenos Aires
Canada
University of Calgary - Foothills Medical Centre
Calgary
St. Michael's Hospital
Toronto
Time Frame
Start Date: 2024-11-26
Completion Date: 2031-07
Participants
Target number of participants: 230
Treatments
Experimental: eShunt System
Endovascular placement of the eShunt Implant
Active_comparator: VP Shunt
Surgical ventriculo-peritoneal shunt procedure
Sponsors
Leads: CereVasc Inc

This content was sourced from clinicaltrials.gov