Clinical trialNCT04801225WithdrawnInterventional

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

SponsorNervive, Inc.Enrollment0Acute Stroke

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Emilio Sacristan, PhD
Nervive, Inc.
Study Director
clinicaltrials.gov ↗
Jon Schrock, MD
MetroHealth System, Ohio
Principal Investigator
clinicaltrials.gov ↗
Ken Uchino, MD
The Cleveland Clinic
Principal Investigator
clinicaltrials.gov ↗
Stephanie Harrington, MS
Nervive, Inc.
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Metrohealth
Cleveland, Ohio, United States
the Cleveland Clinic
Cleveland, Ohio, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 24 Aug 2022
Primary completion: 15 Apr 2025
Completion: 15 Apr 2025
Last update posted: 18 Apr 2025
Registered enrollment: 0
Registry id: NCT04801225

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.