Trials / Withdrawn
WithdrawnNCT04801225
Early Feasibility Study of the Nervive VitalFlow Stimulation for Acute Ischemic Stroke Patients
Early Feasibility Clinical Study of the Nervive VitalFlow Stimulation System for Treatment of Acute Ischemic Stroke Patients
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Nervive, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Non-invasive electromagnetic stimulation for acute stroke treatment | Bilateral electromagnetic stimulation to improve blood flow in ischemic regions of acute stroke as an adjunct to current standard-of-care |
Timeline
- Start date
- 2022-08-24
- Primary completion
- 2025-04-15
- Completion
- 2025-04-15
- First posted
- 2021-03-16
- Last updated
- 2025-04-18
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04801225. Inclusion in this directory is not an endorsement.