Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-25 @ 3:08 AM
NCT ID:
NCT05250505
Brief Summary:
The eShunt System includes proprietary delivery componentry and the eShunt Implant, a permanent implant deployed in a minimally invasive, neurointerventional procedure. The eShunt Implant is designed to mimic the function of the arachnoid granulations by draining excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.
Detailed Description:
This is a prospective, non-randomized, open-label, single-center, pilot study in subjects with normal pressure hydrocephalus for whom a traditional CSF shunt implant is indicated.
Up to 30 subjects will receive the eShunt Implant at one investigational site. Subjects will return for five follow-up visits in the first year and then continue to attend visits every six months for five years post-implantation.
The study objectives are to demonstrate safety of the eShunt Procedure, as well as demonstrate safety and efficacy of the eShunt Implant in a small sample of patients.
Subjects will be followed long-term; primary analysis results will be used to support additional studies.
Study:
NCT05250505
Study Brief:
Protocol Section:
NCT05250505