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

Hydrocephalus Clinical Trial

Official title:
Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus

Clinical Trial Summary

The eShunt System includes proprietary delivery componentry and the eShunt Implant, a permanent implant deployed in a minimally invasive, neurointerventional procedure. The eShunt Implant is designed to mimic the function of the arachnoid granulations by draining excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.

Clinical Trial Description

This is a prospective, non-randomized, open-label, single-center, pilot study in subjects with normal pressure hydrocephalus for whom a traditional CSF shunt implant is indicated. Up to 30 subjects will receive the eShunt Implant at one investigational site. Subjects will return for five follow-up visits in the first year and then continue to attend visits every six months for five years post-implantation. The study objectives are to demonstrate safety of the eShunt Procedure, as well as demonstrate safety and efficacy of the eShunt Implant in a small sample of patients. Subjects will be followed long-term; primary analysis results will be used to support additional studies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05250505
Study type Interventional
Source CereVasc Inc
Contact Ona Whelove
Phone 4155152885
Email clinicaltrials@cerevasc.com
Status Recruiting
Phase N/A
Start date March 10, 2022
Completion date April 2027
View Details
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