TerminatedNot Applicable

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

Stopped: Low enrollment

United States4 participantsStarted 2022-09-15

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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Inclusion criteria

✓. Post-clamping ICP of \> 20 cmH2O for 15 minutes, or
✓. Post-clamping ICP \> 25 cmH2O for \< 15 minutes with patient intolerance to EVD clamping, or
✓. Significant radiographic signs of increasing ventriculomegaly, or
✓. Neurological decline attributable to ventriculomegaly and requiring CSF diversion

What they're measuring

Reduction in ICP

Timeframe: 24-48 hours after eShunt Implant placement

Trial details

NCT IDNCT05501002

SponsorCereVasc Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-15

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