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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05250505 on ClinicalTrials.gov