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

NCT05232838 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-06-19

No results posted yet for this study

Summary

The eShunt® System is a minimally invasive method of treating communicating hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the eShunt Implant, a permanent implant deployed in a minimally invasive, neuro-interventional procedure. The eShunt System is intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system for the treatment of patients with normal pressure hydrocephalus, reducing disability due to symptoms including one or more of gait disturbance, cognitive dysfunction and urinary incontinence.

Conditions

  • Hydrocephalus, Normal Pressure
  • Hydrocephalus

Interventions

DEVICE

eShunt Implant

The eShunt System is intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system for the treatment of patients with normal pressure hydrocephalus, reducing disability due to symptoms including one or more of gait disturbance, cognitive dysfunction and urinary incontinence.

Sponsors & Collaborators

  • AlvaMed, Inc.

    collaborator INDUSTRY

  • Simplified Clinical Data Systems, LLC

    collaborator INDUSTRY

  • CereVasc Inc

    lead INDUSTRY

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
2022-04-20
Primary Completion
2025-06-15
Completion
2030-06-30
FDA Device
Yes

Countries

  • United States

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 NCT05232838 on ClinicalTrials.gov