Actively Recruiting
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Led by CereVasc Inc · Updated on 2026-05-05
230
Participants Needed
31
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Prospective, multi-center, randomized, controlled trial of the eShunt System in the treatment of patients with normal pressure hydrocephalus.
CONDITIONS
Official 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 old 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, including at least two of: gait disturbance, progressive mental deterioration, and urinary urgency or incontinence
- Brain MRI showing ventricular enlargement disproportionate to cerebral atrophy (Evans' Index >0.3) without severe hippocampal atrophy
- Improvement of at least 20% in gait disturbance after a spinal tap test or lumbar drain as measured by the Timed Up and Go Test
- Cerebrospinal fluid opening pressure of 8 cmH2O or higher
- Baseline cognitive function with Montreal Cognitive Assessment (MoCA) score of 12 or higher
- Willing and able to attend all scheduled visits and comply with study procedures
- Suitable anatomy for the eShunt procedure as confirmed by pre-procedure imaging and independent anatomical screening committee
You will not qualify if you...
- Unable to walk 10 meters (33 feet) with or without an assistive device
- Diagnosed with obstructive hydrocephalus
- Active systemic infection or infection detected in cerebrospinal fluid
- Previous or existing shunts, endoscopic third ventriculostomy, or any prior surgical intervention for hydrocephalus
- Hypersensitivity or contraindication to heparin or radiographic contrast agents that cannot be managed
- Occlusion or stenosis of the internal jugular vein preventing access to the internal jugular vein pathway
- Venous distension in the neck on physical exam
- Medical conditions causing prolonged elevation of jugular venous pressure such as jugular vein stenosis, right-sided heart failure, liver cirrhosis, or arteriovenous fistulas
- History of bleeding disorders, coagulopathy, or refusal of blood transfusion in emergencies
- Ischemic stroke or transient ischemic attack within 180 days before the procedure
- Evidence of deep vein thrombosis above the popliteal vein
- Intrinsic blood clotting disorders
- Medical conditions requiring anticoagulation that cannot be managed for surgery
- Presence of posterior fossa tumor or mass
- Life expectancy less than 1 year
- Current participation in another interventional research study that may interfere
- Diagnosis of neurodegenerative diseases like Parkinson's, Alzheimer's, or Lewy body dementia
- Diagnosis of schizophrenia or psychiatric conditions complicating outcome evaluation
- Need for intracranial neurosurgery within 180 days of study procedure
- Unwillingness or inability to comply with follow-up requirements
- Modified Rankin Scale (mRS) score of 0, 5, or 6
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 31 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Actively 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
Actively Recruiting
5
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
6
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States, 60068
Actively Recruiting
7
Indiana University
Indianapolis, Indiana, United States, 46202
Actively 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
Actively Recruiting
13
Henry Ford Health
West Bloomfield, Michigan, United States, 48322
Actively Recruiting
14
Cooper Neurological Institute
Camden, New Jersey, United States, 08103
Active, Not Recruiting
15
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
16
University at Buffalo Neurosurgery
Buffalo, New York, United States, 14203
Actively Recruiting
17
Northwell Health
Manhasset, New York, United States, 11030
Actively 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
Actively 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
Actively Recruiting
23
Montefiore Medical Center
The Bronx, New York, United States, 10467
Actively 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
Actively 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
Actively Recruiting
Research Team
O
Ona Whelove
CONTACT
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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