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

NCT06498960 | Recruiting DMC FDA Device

• 1 other identifier: CLIN 0036
• Study Type: interventional
• Target: 230
• Locations: 3 countries
• Sites: 31

Brief Summary

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

Conditions

Normal Pressure Hydrocephalus

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness Endpoint

  The Primary Effectiveness Endpoint of this study is change in gait impairment at 6-months, compared to baseline. Change in gait impairment is defined as reduction in time required to complete the Timed Up and Go (TUG) test (stand up, walk 3m, turnaround, walk 3m, sit down).

  6 months

• Primary Safety Endpoint

  All adverse events will be reported for the investigational (eShunt System) and control (VP shunt) arms. Safety will be analyzed based on a review of all AEs in the investigational arm compared to the control arm, through 6-months post-procedure to demonstrate an acceptable safety profile of the eShunt System.

  6 months

Study Arms (2)

eShunt System

EXPERIMENTAL

Endovascular placement of the eShunt Implant

Device: CereVasc eShunt System

VP Shunt

ACTIVE COMPARATOR

Surgical ventriculo-peritoneal shunt procedure

Device: VP Shunt

Interventions

CereVasc eShunt System DEVICE

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

Also known as: eShunt System, eShunt Implant

eShunt System

VP Shunt DEVICE

Control arm - VP shunt

VP Shunt

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Each subject may not:
• Be unable to walk 10 meters (33 feet) with or without an assistive device
• Be diagnosed with obstructive hydrocephalus
• Have an active systemic infection or infection detected in CSF
• Have had prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
• Demonstrate hypersensitivity or contraindication to heparin or radiographic contrast agents against which the subject cannot be adequately pre-medicated, desensitized or where no alternative is available
• Have occlusion or stenosis of the internal jugular vein which would prohibit access to the IPS
• Present with venous distension in the neck on physical exam
• Have medical conditions associated with prolonged elevation of jugular venous pressure, including jugular vein stenosis or stricture, right sided heart failure, cirrhosis of the liver, arteriovenous fistulas in the arm for dialysis purposes, or an arterial venous fistula or malformation in the neck or brain
• Have history of bleeding diatheses, coagulopathy or refuse to consent for blood transfusion in cases of emergency
• Have had an ischemic stroke or transient ischemic attack within 180 days of eShunt procedure
• Have documented evidence of a deep vein thrombosis superior to the popliteal vein
• Have intrinsic blood clotting disorder
• Have medical conditions requiring anticoagulation which is unable to be managed to allow for surgical procedure
• Have presence of a posterior fossa tumor or mass

Sponsors & Collaborators

• CereVasc Inc: lead

Study Sites (31)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

Yale University

New Haven, Connecticut, 06511, United States

RECRUITING

Baptist Medical Center - Jacksonville

Jacksonville, Florida, 32207, United States

RECRUITING

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

University of Kentucky Research Foundation

Lexington, Kentucky, 40506, United States

ACTIVE NOT RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

ACTIVE NOT RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

ACTIVE NOT RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Henry Ford Health

West Bloomfield, Michigan, 48322, United States

RECRUITING

Cooper Neurological Institute

Camden, New Jersey, 08103, United States

ACTIVE NOT RECRUITING

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

University at Buffalo Neurosurgery

Buffalo, New York, 14203, United States

RECRUITING

Northwell Health

Manhasset, New York, 11030, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

Lenox Hill Hospital

New York, New York, 10075, United States

RECRUITING

University of Rochester Medical Center

Rochester, New York, 14642, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

ACTIVE NOT RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Clinica La Sagrada Familia

Buenos Aires, C1426B, Argentina

RECRUITING

University of Calgary - Foothills Medical Centre

Calgary, Alberta, T2N 4N1, Canada

RECRUITING

St. Michael's Hospital

Toronto, Ontario, M5C 2W6, Canada

RECRUITING

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Interventions

Ventriculoperitoneal Shunt

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cerebrospinal Fluid Shunts; Anastomosis, Surgical; Surgical Procedures, Operative; Neurosurgical Procedures

Central Study Contacts

Ona Whelove

CONTACT

917-275-5340; clinicaltrials@cerevasc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: November 26, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2031
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1); CA (2); US (28)