NCT07489326

The SetPoint System Safety & Performance Post-Approval Study

The SetPoint System Safety & Performance Post-Approval Study (ACTIVATE Study)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: SetPoint Medical Corporation · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The registry will follow a prospective, multi-center, observational design with data collection at predefined intervals for up to three (3) years. All participants will have received the SetPoint System as part of routine clinical care, and no study-specific interventions are required. Data about the surgical procedure will be obtained from training records, implant procedure checklists, and other available records and entered into study-specific electronic case report forms (eCRFs). Additionally, data will be captured during scheduled follow-up at the Rheumatology clinic, using a combination of study-specific worksheets and the automatic transfer of device-specific performance data that is captured in the SetPoint Cloud Infrastructure. User feedback (including both complaints and non-complaints) will also be collected. The compilation of this data will allow monitoring of safety, effectiveness, device performance, and usability in a real-world setting.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2026-04-15
• Primary completion: 2031-01-01
• Completion: 2031-01-01
• First posted: 2026-03-24
• Last updated: 2026-03-24

Regulatory

• FDA-regulated device study