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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
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

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.