RecruitingNot Applicable

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

United States230 participantsStarted 2024-11-26

Plain-language summary

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

Age range60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. Be unable to walk 10 meters (33 feet) with or without an assistive device
✕. Be diagnosed with obstructive hydrocephalus
✕. Have an active systemic infection or infection detected in CSF
✕. Have had prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
✕. 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
✕. Have occlusion or stenosis of the internal jugular vein which would prohibit access to the IPS
✕. Present with venous distension in the neck on physical exam
✕. 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

Primary Effectiveness Endpoint

Timeframe: 6 months

Primary Safety Endpoint

Timeframe: 6 months

NCT IDNCT06498960

SponsorCereVasc Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Ona Whelove

Who can participate

Age range60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

✕. Be unable to walk 10 meters (33 feet) with or without an assistive device
✕. Be diagnosed with obstructive hydrocephalus
✕. Have an active systemic infection or infection detected in CSF
✕. Have had prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
✕. 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
✕. Have occlusion or stenosis of the internal jugular vein which would prohibit access to the IPS
✕. Present with venous distension in the neck on physical exam
✕. 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