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ACTIVE NOT RECRUITING
NCT04862117
NA

Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)

Sponsor: SetPoint Medical Corporation

View on ClinicalTrials.gov

Summary

Long-term extension of a multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two biologic and/or targeted synthetic DMARDs having at least two different mechanisms of action

Official title: Long Term Extension Study of the Safety and Efficacy of Neurostimulation Using a Vagus Nerve Stimulation Device in Patients With Rheumatoid Arthritis

Key Details

Gender

All

Age Range

22 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2018-07-28

Completion Date

2026-12-08

Last Updated

2025-05-13

Healthy Volunteers

No

Interventions

DEVICE

SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System

Active Implantable Vagus Nerve Stimulation device.

Locations (4)

Arthritis & Rheumatic Disease Specialties

Aventura, Florida, United States

Florida Medical Clinic, PA

Zephyrhills, Florida, United States

Northwell Health

Great Neck, New York, United States

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States