The SetPoint System Safety & Performance Post-Approval Study

Sponsor
SetPoint Medical Corporation
Study ID
NCT07489326
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SetPoint System — DEVICE
    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)

Study Details

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.

Key Dates

First listed
Mar 24, 2026
Start date
Apr 15, 2026
Status verified
Mar 2026
Primary completion
Jan 1, 2031
Completion
Jan 1, 2031

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: SetPoint System users
    Patients indicated for the SetPoint System in whom the implant procedure for the SetPoint System has been attempted

Primary Outcome Measure

Clinical Disease Activity Index (CDAI) [ Time Frame: 3 years ]

Central Contacts

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Rheumatoid arthritis trialsRheumatology trialsAutoimmune disease trialsMusculoskeletal disorders trials

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