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The SetPoint System Safety & Performance Post-Approval Study
Sponsor: SetPoint Medical Corporation
Summary
Prospective, multicenter, post-market, registry study designed to systematically collect real-world data (RWD) from participants implanted with the SetPoint System \[implanted, vagus-mediated, neuroimmune modulator\] for the treatment of adults with moderately to severely active rheumatoid arthritis (RA). The registry will assess adherence to surgical training, device performance, system usability, safety, and clinical outcomes as reported in clinical practice.
Official title: The SetPoint System Safety & Performance Post-Approval Study (ACTIVATE Study)
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2026-04-15
Completion Date
2031-01-01
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
SetPoint System
implanted, vagus-mediated neuroimmune modulator for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response or intolerance to one or more biological or targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs)