The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Sh… (NCT04758611) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt)
Argentina20 participantsStarted 2020-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \> 18
. Subject provides Informed Consent (IC)
. Post-aneurysmal SAH with Hunt and Hess Grades I-IV with EVD in place with the need for a permanent CSF shunt determined through a failed EVD clamping trial defined as:
. Post-clamping ICP of \> 20 cmH2O for 15 min, or
. Post-clamping ICP \> 25 cmH2O for \< 15 min with patient intolerance to EVD clamping
. Post-clamping ICP \>15 cmH2O for 15 min with radiographic evidence of ventriculomegaly
. Clinical signs and symptoms of communicating hydrocephalus
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in intracranial pressure (ICP)
Timeframe: 36-48 hours following eShunt Implant deployment
. Neurologically stable without evidence of severe vasospasm
Exclusion criteria
. Patient is in a state of unconsciousness or is unable to understand the information provided in the Informed Consent Form for this study
. Indication of obstructive hydrocephalus
. Presence of gross blood in CSF from EVD
. Pregnant
. Unwilling or unable to comply with follow up requirements
. Active systemic infection or infection detected in CSF
. Life expectancy \< 1 year
. Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available