Minimally invasive treatment for normal pressure hydrocephalus
Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® EShunt® System in the Treatment of Normal Pressure Hydrocephalus
This study is testing a new device that helps drain extra fluid in the brains of people with normal pressure hydrocephalus to see if it can improve their symptoms safely.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | CereVasc Inc Industry-sponsored |
| Locations | 1 site (Buenos Aires, Ciudad A. de Buenos Aires) |
| Trial ID | NCT05250505 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the eShunt System, a minimally invasive device designed to drain excess cerebrospinal fluid (CSF) in patients with normal pressure hydrocephalus (NPH). The study will enroll up to 30 subjects who meet specific criteria, including age and clinical presentation consistent with NPH. Participants will receive the eShunt Implant through a neurointerventional procedure and will be monitored for safety and efficacy over a five-year period with regular follow-up visits. The primary goal is to assess the safety of the procedure and the effectiveness of the implant in improving symptoms associated with NPH.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65-85 with a diagnosis of normal pressure hydrocephalus who are indicated for traditional CSF shunt placement.
Not a fit: Patients with severe cognitive impairment or those who do not meet the specific diagnostic criteria for normal pressure hydrocephalus may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients with normal pressure hydrocephalus.
How similar studies have performed: While this approach is innovative, similar minimally invasive techniques have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients 65-85 years old and traditional CSF shunt placement is indicated based upon a diagnostic NPH evaluation 2. Patient is able and willing to provide written informed consent 3. History or evidence of gait impairment duration ≥6 months 4. Clinical presentation consistent with NPH including 2 or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with: 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 with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20% 3. CSF opening pressure ≥10 cmH2O 4. Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12 5. Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC 6. Pre-procedure CT confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC Exclusion Criteria: 1. Unable to walk 10 meters (33 feet) with or without an assistive device 2. Conditions impairing gait that are considered to be unrelated to hydrocephalus 3. Signs or symptoms of obstructive hydrocephalus 4. Active systemic infection or infection detected in CSF 5. Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus 6. Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available 7. Occlusion or stenosis of the internal jugular vein 8. Venous distension in the neck on physical exam 9. Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram 10. History of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency 11. Stroke or transient ischemic attack within 180 days of eShunt Procedure 12. Presence of a deep vein thrombosis superior to the popliteal vein 13. International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 seconds) 14. Presence of a posterior fossa tumor or mass 15. Life expectancy \< 1 year 16. Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up 17. Other medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation 18. Pregnant or planning to become pregnant 19. Unwilling or unable to comply with follow-up requirements
Where this trial is running
Buenos Aires, Ciudad A. de Buenos Aires
- Clínica La Sagrada Familia — Buenos Aires, Ciudad A. de Buenos Aires, Argentina (Recruiting)
Study contacts
- Principal investigator: Pedro Lylyk, MD — Clínica La Sagrada Familia
- Study coordinator: Ona Whelove
- Email: clinicaltrials@cerevasc.com
- Phone: 4155152885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.