Status:
ACTIVE_NOT_RECRUITING
Long Term Extension of Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)
Lead Sponsor:
SetPoint Medical Corporation
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
22-75 years
Phase:
NA
Brief 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 r...
Detailed Description
A multicenter, extension study to assess long term safety and efficacy of an active implantable VNS device in adult patients with rheumatoid arthritis. The study is uncontrolled and randomized, where ...
Eligibility Criteria
Inclusion
- Subjects must have enrolled and completed 12 weeks of treatment in Study SPM-008
- Women of childbearing potential must not be pregnant and must agree to use a reliable method of contraception throughout the study
Exclusion
- Inability to provide consent
- An adverse event during Study SPM-008 which precludes participation in this study
- Any condition per the investigator's clinical judgement that precludes participation in the study
Key Trial Info
Start Date :
July 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2026
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04862117
Start Date
July 28 2018
End Date
December 8 2026
Last Update
May 13 2025
Active Locations (4)
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1
Arthritis & Rheumatic Disease Specialties
Aventura, Florida, United States, 33180
2
Florida Medical Clinic, PA
Zephyrhills, Florida, United States, 33542
3
Northwell Health
Great Neck, New York, United States, 11021
4
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635