The SetPoint System Safety & Performance Post-Approval Study (ACTIVATE Study)
NCT: NCT07489326 ·
Status: NOT YET RECRUITING ·
Phase: N/A
· Sponsor: SetPoint Medical Corporation
· Started: 2026-04-15
· Est. Completion: 2031-01-01
Official 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.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 150 participants
Interventions
- DEVICE: 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)
Primary Outcomes
- Clinical Disease Activity Index (CDAI) (3 years)
More Rheumatoid Arthritis Trials
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.