Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758611
Status:
RECRUITING
Last Update Posted:
2024-01-10
First Post:
2021-02-09
Brief Title:
The ETCHES I Study Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt
Sponsor:
CereVasc Inc
Organization:
CereVasc Inc
Study Overview
Official Title:
Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc eShunt System in the Treatment of Communicating Hydrocephalus
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETCHES I
Brief 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 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 single-center open label single-arm 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 following the hemorrhagic event
The study will be performed a single site with up to 30 subjects who meet the inclusion and exclusion criteria for the study Subjects will be evaluated every 30 days for the first 90 days following eShunt Implant deployment with standard neurological evaluation appropriate for patients with communicating hydrocephalus In addition follow-up will occur at 180 days 12 and 24 months post-operatively and will include imaging in addition to the standard neurological evaluation
The study will be performed a single site with up to 30 subjects who meet the inclusion and exclusion criteria for the study Subjects will be evaluated every 30 days for the first 90 days following eShunt Implant deployment with standard neurological evaluation appropriate for patients with communicating hydrocephalus In addition follow-up will occur at 180 days 12 and 24 months post-operatively and will include imaging in addition to the standard neurological evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None