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The SetPoint System Safety & Performance Post-Approval Study

Not Yet RecruitingN/A

Sponsor: SetPoint Medical Corporation

Conditions: Rheumatoid Arthritis

Interventions: SetPoint System

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.

Eligibility overview

Sex: ALL

Age: 22 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* Contraindicated for the SetPoint System