The SetPoint System Safety & Performance Post-Approval Study
ConditionRheumatoid Arthritis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorSetPoint Medical Corporation
About this trial
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 criteria
Qualifiers
Indicated for the SetPoint System
Implant procedure for the SetPoint System has been attempted
Willing to sign Informed Consent Form
Disqualifiers
Contraindicated for the SetPoint System
Trial design
Treatments tested in this trial
- SetPoint System
Treatment groups
150 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov