U.S., March 25 -- ClinicalTrials.gov registry received information related to the study (NCT07489326) titled 'The SetPoint System Safety & Performance Post-Approval Study' on March 19.
Brief 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 Start Date: April 15
Study Type: OBSERVATIONAL
Condition:
Rheumatoid Arthri...