The SetPoint System Safety & Performance Post-Approval Study

Starting soon

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT07489326

Run by

SetPoint Medical Corporation

People needed

150

Starts

2026-04-15

Expected to finish

2031-01-01

Last updated by the study team

2026-03-24

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Indicated for the SetPoint System
• Implant procedure for the SetPoint System has been attempted
• Willing to sign Informed Consent Form

You may not qualify if…

• Contraindicated for the SetPoint System

Full record on ClinicalTrials.gov

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