Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
NCT05250505 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-03-18
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.
Conditions
- Hydrocephalus, Normal Pressure
- Hydrocephalus
Interventions
- DEVICE
-
eShunt Implant
The eShunt System consists of endovascular delivery componentry and a permanent implant intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system in adults.
Sponsors & Collaborators
-
AlvaMed, Inc.
collaborator INDUSTRY -
Simplified Clinical Data Systems, LLC
collaborator INDUSTRY -
Bioscience Consulting, Inc.
collaborator INDUSTRY -
CereVasc Inc
lead INDUSTRY
Principal Investigators
-
Pedro Lylyk, MD · Clínica La Sagrada Familia
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 65 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-10
- Primary Completion
- 2025-04-23
- Completion
- 2030-04-30
- FDA Device
- Yes
Countries
- Argentina
Study Locations
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