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Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)
Sponsor: SetPoint Medical Corporation
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
Conditions
Interventions
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