NCT07489326Not yet recruiting
The SetPoint System Safety & Performance Post-Approval Study
The SetPoint System Safety & Performance Post-Approval Study (ACTIVATE Study)
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 19 Mar 2026
- Start date
- 15 Apr 2026
- Primary completion date
- 1 Jan 2031
- Lead sponsor
- SetPoint Medical Corporation
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07489326
What you commit to
- Study type: Observational
- Planned participants: 150
- From 15 Apr 2026 to the primary completion date, 1 Jan 2031
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Contraindicated for the SetPoint System
Who the study is looking for
- Indicated for the SetPoint System
- Implant procedure for the SetPoint System has been attempted
- Willing to sign Informed Consent Form
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.