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

Status: Recruiting
Location: See all (28) 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
RECRUITING
Los Angeles
Connecticut
Yale University
RECRUITING
New Haven
Florida
Baptist Medical Center - Jacksonville
RECRUITING
Jacksonville
University of South Florida
RECRUITING
Tampa
Illinois
Northwestern University
RECRUITING
Chicago
Advocate Lutheran General Hospital
RECRUITING
Park Ridge
Indiana
Indiana University
RECRUITING
Indianapolis
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Kentucky
University of Kentucky Research Foundation
RECRUITING
Lexington
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Brigham and Women's Hospital
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Michigan
Henry Ford Health
RECRUITING
West Bloomfield
New Jersey
Cooper Neurological Institute
RECRUITING
Camden
New York
Albany Medical Center
RECRUITING
Albany
University at Buffalo Neurosurgery
RECRUITING
Buffalo
Northwell Health
RECRUITING
Manhasset
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Lenox Hill Hospital
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
University of Rochester Medical Center
RECRUITING
Rochester
Montefiore Medical Center
RECRUITING
The Bronx
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Other Locations
Argentina
Clinica La Sagrada Familia
RECRUITING
Buenos Aires
Canada
St. Michael's Hospital
RECRUITING
Toronto
Contact Information
Primary
Ona Whelove
clinicaltrials@cerevasc.com
917-275-5340
Time Frame
Start Date: 2024-11-26
Estimated Completion Date: 2031-01-01
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