Actively Recruiting
Pivotal Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus
Led by CereVasc Inc · Updated on 2026-06-02
230
Participants Needed
31
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, multi-center, randomized, controlled trial to evaluate the eShunt System in treating patients with normal pressure hydrocephalus (NPH). This study aims to assess the safety and effectiveness of this device compared to the standard ventriculo-peritoneal (VP) shunt in patients aged 60 years and older who show clinical signs of NPH and gait impairment. Participants will be randomly assigned to receive either the endovascular placement of the eShunt Implant or the surgical VP shunt procedure. The eShunt System includes the implant itself, a delivery catheter, a transfer tool, and an anchor. The study includes a 6-month follow-up period where researchers will monitor both effectiveness and safety outcomes. During the study, participants will undergo scheduled visits with various assessments, including brain imaging, cognitive evaluation using the Montreal Cognitive Assessment (MoCA), and gait tests such as the Timed Up and Go Test. Researchers will also evaluate safety endpoints and monitor adherence to study procedures. The study is expected to continue until June 2031, with ongoing assessment of participant health and device performance.
CONDITIONS
Brief Title
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 60 years or older on the day of informed consent
- Patient or legally authorized representative able and willing to provide written informed consent
- History or evidence of gait impairment lasting 3 months or more
- Clinical presentation consistent with normal pressure hydrocephalus (NPH) including at least two of the triad: gait disturbance, progressive mental deterioration, urinary urgency or incontinence
- Brain MRI showing ventricular enlargement disproportionate to cerebral atrophy and absence of severe hippocampal atrophy
- Improvement of at least 20% in gait after spinal tap test or lumbar drain
- Cerebrospinal fluid (CSF) opening pressure 8 cmH2O or higher
- Baseline cognitive evaluation with Montreal Cognitive Assessment (MoCA) score of 12 or higher
- Willing and able to attend all scheduled visits and comply with study procedures
- Confirmation of anatomy suitable for the eShunt procedure by imaging evaluation and independent anatomical screening committee approval
You will not qualify if you...
- Unable to walk 10 meters (33 feet) with or without assistive device
- Diagnosed with obstructive hydrocephalus
- Active systemic infection or infection detected in cerebrospinal fluid
- Prior or existing shunts, endoscopic third ventriculostomy, or previous surgical intervention for hydrocephalus
- Hypersensitivity or contraindication to heparin or radiographic contrast agents without alternatives
- Occlusion or stenosis of internal jugular vein prohibiting access to the inferior petrosal sinus (IPS)
- Venous distension in the neck on physical exam
- Medical conditions causing prolonged elevated jugular venous pressure (e.g., jugular vein stenosis, right sided heart failure, liver cirrhosis, arteriovenous fistulas)
- History of bleeding disorders or refusal of blood transfusion in emergencies
- Ischemic stroke or transient ischemic attack within 180 days before procedure
- Documented deep vein thrombosis above the popliteal vein
- Intrinsic blood clotting disorder
- Medical conditions requiring anticoagulation that cannot be managed for surgery
- Presence of posterior fossa tumor or mass
- Life expectancy less than 1 year
- Participation in another interventional research project that may affect results
- Diagnosed neurodegenerative diseases like Parkinson's, Alzheimer's, or Lewy body dementia
- Diagnosed schizophrenia or psychiatric conditions complicating outcome evaluation
- Need for intracranial neurosurgical procedure within 180 days of study procedure
- Unwilling or unable to comply with follow-up requirements
- Modified Rankin Scale score of 0, 5, or 6
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure plus immediate recovery
Participants undergo either the endovascular placement of the eShunt Implant or a surgical ventriculo-peritoneal shunt procedure as part of the trial.
1 procedure visit (in-person)
Duration - 6 months
Participants are monitored for safety and effectiveness outcomes following the implantation procedure.
Multiple follow-up visits over 6 months
Trial Site Locations
Total: 31 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Active, Not Recruiting
2
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
3
Baptist Medical Center - Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
4
University of South Florida
Tampa, Florida, United States, 33606
Active, Not Recruiting
5
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
6
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
Active, Not Recruiting
7
Indiana University
Indianapolis, Indiana, United States, 46202
Active, Not Recruiting
8
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
9
University of Kentucky Research Foundation
Lexington, Kentucky, United States, 40506
Active, Not Recruiting
10
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Active, Not Recruiting
11
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Active, Not Recruiting
12
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Active, Not Recruiting
13
Henry Ford Health
West Bloomfield, Michigan, United States, 48322
Active, Not Recruiting
14
Cooper Neurological Institute
Camden, New Jersey, United States, 08103
Active, Not Recruiting
15
Albany Medical Center
Albany, New York, United States, 12208
Active, Not Recruiting
16
University at Buffalo Neurosurgery
Buffalo, New York, United States, 14203
Active, Not Recruiting
17
Northwell Health
Manhasset, New York, United States, 11030
Active, Not Recruiting
18
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
19
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Active, Not Recruiting
20
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
21
Lenox Hill Hospital
New York, New York, United States, 10075
Actively Recruiting
22
University of Rochester Medical Center
Rochester, New York, United States, 14642
Active, Not Recruiting
23
Montefiore Medical Center
The Bronx, New York, United States, 10467
Active, Not Recruiting
24
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
25
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
26
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Active, Not Recruiting
27
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Active, Not Recruiting
28
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
29
Clinica La Sagrada Familia
Buenos Aires, Argentina, C1426B
Actively Recruiting
30
University of Calgary - Foothills Medical Centre
Calgary, Alberta, Canada, T2N 4N1
Actively Recruiting
31
St. Michael's Hospital
Toronto, Ontario, Canada, M5C 2W6
Active, Not Recruiting
Research Team
O
Ona Whelove
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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