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Pilot Study to Evaluate the CereVasc® EShunt® System in the Treatment of Communicating Hydrocephalus

NCT05501002 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-11-22

No results posted yet for this study

Summary

The purpose of this study will be to evaluate a novel, minimally invasive method of treating hydrocephalus in adults. The eShunt® System includes a proprietary eShunt® Delivery System and the eShunt® Implant, a permanent implant that is deployed in a mildly invasive, neuro-interventional procedure. The eShunt® Implant is designed to drain excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.

Conditions

  • Hydrocephalus
  • Hydrocephalus, Communicating

Interventions

DEVICE

eShunt® Implant

The eShunt® Implant is intended to drain excess cerebrospinal fluid from the intracranial subarachnoid space to the venous system as a less invasive therapy for treating hydrocephalus.

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
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2023-09-15
Completion
2023-09-15
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 NCT05501002 on ClinicalTrials.gov