CereVasc eShunt System for Normal Pressure Hydrocephalus
This study is evaluating the safety and effectiveness of the CereVasc® eShunt® System for people with Normal Pressure Hydrocephalus (NPH). NPH is a condition that can cause problems with walking, thinking, and bladder control. The eShunt System is a device being compared to the standard VP Shunt (another device). Researchers want to see if the eShunt System helps improve symptoms and is safe to use. You may be able to join if you are 60 years or older, have gait (walking) problems for at least three months, and have NPH symptoms. The study aims to enroll 230 participants. The study is looking at how well the eShunt works and its safety over 6 months.
- Study design
- This is a randomized, controlled study comparing the eShunt System to the VP Shunt. It plans to include 230 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for effectiveness and safety for 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
At a glance
Conditions
Where it's being run
32 sites across 19 statesWho to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Primary Effectiveness Endpoint6 months
The Primary Effectiveness Endpoint of this study is change in gait impairment at 6-months, compared to baseline. Change in gait impairment is defined as reduction in time required to complete the Timed Up and Go (TUG) test (stand up, walk 3m, turnaround, walk 3m, sit down).
- Primary Safety Endpoint6 months
All adverse events will be reported for the investigational (eShunt System) and control (VP shunt) arms. Safety will be analyzed based on a review of all AEs in the investigational arm compared to the control arm, through 6-months post-procedure to demonstrate an acceptable safety profile of the eShunt System.