RECRUITING

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

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-11-30

Study Completion:2031-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06498960

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patients ≥60 years old on the day of study informed consent 2. Patient or legally authorized representative is able and willing to provide written informed consent 3. History or evidence of gait impairment with a duration ≥3 months 4. 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: 1. Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index \>0.3) and the absence of severe hippocampal atrophy, 2. Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%, 3. CSF opening pressure ≥8 cmH2O, 4. Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12 5. Patient is willing and able to attend all scheduled visits and comply with study procedures. 6. 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.	1. Be unable to walk 10 meters (33 feet) with or without an assistive device 2. Be diagnosed with obstructive hydrocephalus 3. Have an active systemic infection or infection detected in CSF 4. Have had prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus 5. 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 6. Have occlusion or stenosis of the internal jugular vein which would prohibit access to the IPS 7. Present with venous distension in the neck on physical exam 8. 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 9. Have history of bleeding diatheses, coagulopathy or refuse to consent for blood transfusion in cases of emergency 10. Have had an ischemic stroke or transient ischemic attack within 180 days of eShunt procedure 11. Have documented evidence of a deep vein thrombosis superior to the popliteal vein 12. Have intrinsic blood clotting disorder 13. Have medical conditions requiring anticoagulation which is unable to be managed to allow for surgical procedure 14. Have presence of a posterior fossa tumor or mass 15. Have a life expectancy \<1 year 16. Be currently participating in another interventional (drug, device, etc.) research project that may confound the results of this study. 17. Have established diagnosis of neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, or Lewy body dementia 18. Be diagnosed with schizophrenia or any psychiatric diagnosis (including depression) that may complicate outcome evaluation 19. Need an intracranial neurosurgical procedure within 180 days of study index procedure 20. Be unwilling or unable to comply with follow-up requirements 21. Have mRS of 0, 5, or 6

Inclusion Criteria

Exclusion Criteria

1. Patients ≥60 years old on the day of study informed consent
2. Patient or legally authorized representative is able and willing to provide written informed consent
3. History or evidence of gait impairment with a duration ≥3 months
4. 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:
1. Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index \>0.3) and the absence of severe hippocampal atrophy,
2. Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%,
3. CSF opening pressure ≥8 cmH2O,
4. Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
5. Patient is willing and able to attend all scheduled visits and comply with study procedures.
6. 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.

1. Be unable to walk 10 meters (33 feet) with or without an assistive device
2. Be diagnosed with obstructive hydrocephalus
3. Have an active systemic infection or infection detected in CSF
4. Have had prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
5. 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
6. Have occlusion or stenosis of the internal jugular vein which would prohibit access to the IPS
7. Present with venous distension in the neck on physical exam
8. 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
9. Have history of bleeding diatheses, coagulopathy or refuse to consent for blood transfusion in cases of emergency
10. Have had an ischemic stroke or transient ischemic attack within 180 days of eShunt procedure
11. Have documented evidence of a deep vein thrombosis superior to the popliteal vein
12. Have intrinsic blood clotting disorder
13. Have medical conditions requiring anticoagulation which is unable to be managed to allow for surgical procedure
14. Have presence of a posterior fossa tumor or mass
15. Have a life expectancy \<1 year
16. Be currently participating in another interventional (drug, device, etc.) research project that may confound the results of this study.
17. Have established diagnosis of neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, or Lewy body dementia
18. Be diagnosed with schizophrenia or any psychiatric diagnosis (including depression) that may complicate outcome evaluation
19. Need an intracranial neurosurgical procedure within 180 days of study index procedure
20. Be unwilling or unable to comply with follow-up requirements
21. Have mRS of 0, 5, or 6

Contacts and Locations

Study Contact

Ona Whelove

CONTACT

4155152885

clinicaltrials@cerevasc.com

Randy Burrington

CONTACT

clinicaltrials@cerevasc.com

Study Locations (Sites)

Virginia Commonwealth University

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: CereVasc Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-30

Study Completion Date2031-01-01

Study Record Updates

Study Start Date2024-11-30

Study Completion Date2031-01-01

Terms related to this study

Additional Relevant MeSH Terms

Normal Pressure Hydrocephalus