Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Normal Pressure Hydrocephalus
• Age: Between 65 Year(s) - 85 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Patients 65-85 years old for whom traditional CSF shunt placement is indicated based upon a diagnostic NPH evaluation
  2. Patient or legally authorized representative is able and willing to provide written informed consent
  3. History or evidence of gait impairment duration of at least 6 months
  4. Clinical presentation consistent with NPH
  5. Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure
  6. Pre-procedure CT confirmation of anatomy suitable for eShunt Procedure

  
  

You may not be eligible for this study if the following are true:

• 1. Unable to walk 10 meters (33 feet) with or without an assistive device
  2. Signs or symptoms of obstructive hydrocephalus
  3. Active systemic infection or infection detected in CSF
  4. Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
  5. Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available
  6. Occlusion or stenosis of the internal jugular vein
  7. Venous distension in the neck on physical exam
  8. Medical conditions associated with prolonged elevation of jugular venous pressure, including jugular vein stenosis or stricture, right sided heart failure, cirrhosis of the liver, arterial venous fistulas in the arm for dialysis purposes, or an arterial venous fistula or malformation in the neck or brain
  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
  14. Presence of a posterior fossa tumor or mass
  15. Life expectancy of less than 1 year
  16. Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up
  17. Established neurodegenerative diseases such as Parkinson’s disease, Alzheimer’s disease, or Lewy body dementia
  18. Unwilling or unable to comply with follow-up requirements