The SetPoint System Safety & Performance Post-Approval Study

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.

NCT Number	NCT07489326
Lead Sponsor	SetPoint Medical Corporation
Conditions	Rheumatoid Arthritis
Enrollment	150 participants
Start Date	2026-04-15
Primary Completion	2031-01-01 (estimated)
Study Completion	2031-01-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-24