Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus

Launched by CEREVASC INC · Feb 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the eShunt System, which is designed to help patients with Normal Pressure Hydrocephalus (NPH). NPH is a condition where excess cerebrospinal fluid builds up in the brain, leading to problems like difficulty walking, memory issues, and urgent need to urinate. The eShunt System aims to drain this excess fluid safely and effectively through a minimally invasive procedure.

To participate in this trial, participants need to be between 65 and 85 years old, have experienced walking difficulties for at least six months, and meet certain medical criteria related to NPH. Participants will receive the eShunt Implant and will be monitored to see how well it helps improve their symptoms. It's important to note that not everyone will qualify for this study; there are specific health conditions that could disqualify someone. Overall, this trial offers a potential new treatment option for those struggling with NPH and aims to improve their quality of life.

Gender

ALL

Eligibility 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