NCT05501002

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

US Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® EShunt® System in the Treatment of Communicating Hydrocephalus

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: CereVasc Inc · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multi-center, open label, pilot study of the eShunt® System. The study population consists of patients with post-aneurysmal subarachnoid hemorrhage (SAH) treated for increased intracranial pressure (ICP) resulting in symptomatic hydrocephalus using an external ventricular drain (EVD) to facilitate CSF drainage and who cannot be "weaned" from the EVD after the hemorrhagic event. After completion of the procedure to place the eShunt® device, the ICP will be monitored and recorded for up to 48 hours. Subjects will then return for follow-up visits that include standard neurological evaluations at 30, 60, 90, 180, and 365 days postimplantation; imaging will also be acquired at 30, 90 and 365 days after implant. Subjects will continue to attend follow-up visits every 180 days thereafter until the study is closed or up to 5 years post-implantation.

Conditions

• Hydrocephalus
• Hydrocephalus, Communicating

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-09-15
• Primary completion: 2023-09-15
• Completion: 2023-09-15
• First posted: 2022-08-15
• Last updated: 2024-11-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study