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The SetPoint System Safety & Performance Post-Approval Study

NCT07489326 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-03-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

SetPoint System

implanted, vagus-mediated neuroimmune modulator for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response or intolerance to one or more biological or targeted synthetic disease modifying antirheumatic drugs (b/tsDMARDs)

Sponsors & Collaborators

  • SetPoint Medical Corporation

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2031-01-01
Completion
2031-01-01
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07489326 on ClinicalTrials.gov