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Early Feasibility Study of the Nervive VitalFlow Stimulation for Acute Ischemic Stroke Patients

Acute Stroke Clinical Trial

Official title:
Early Feasibility Clinical Study of the Nervive VitalFlow Stimulation System for Treatment of Acute Ischemic Stroke Patients

Clinical Trial Summary

This Early Feasibility Study (EFS) is a multi-center, open-label single-arm study in 10 acute ischemic stroke (AIS) patients treated with VitalFlow-IS stimulation within 6 hours of symptom onset. The purpose of the EFS is to evaluate initial clinical safety and device functionality in the clinical workflow setting for treatment of acute ischemic stroke patients that will inform design modifications and/or user interface in preparation for next steps consisting of (1) a full safety/feasibility clinical study and (2) randomized controlled pivotal trial with a surrogate endpoint (expedited Premarket Approval (PMA) pathway).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04801225
Study type Interventional
Source Nervive, Inc.
Contact Stephanie Harrington, MS
Phone 440 796-0619
Email sharrington@nervive.com
Status Recruiting
Phase N/A
Start date August 24, 2022
Completion date August 31, 2023
View Details
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