The SetPoint System Safety & Performance Post-Approval Study

NCT07489326 | Not Yet Recruiting FDA Device

• 1 other identifier: SPM-021
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Vagus nerve; vagus nerve stimulating device; permanent implantable; implant

Outcome Measures

Primary Outcomes (1)

• Clinical Disease Activity Index (CDAI)

  The CDAI score is based on 4 items: * Tender joint count of 28 joints (TJC28). Scale: 0=best to 28=worst * Swollen joint count of 28 joints (SJC28). Scale: 0=best to 28=worst * Subject global assessment (SGA). Scale: 0=best to 10=worst * Evaluator's global assessment (EGA). Scale: 0=best to 10=worst The CDAI score is calculated as follows and ranges from 0 to 76: • CDAI = TJC28 + SJC28 + SGA + EGA The CDAI score corresponds to the current RA activity: * 0 to ≤ 2.8 Remission * \>2.8 to ≤ 10 Low disease activity (LDA) * \>10 to ≤ 22 Moderate disease activity * \> 22 High disease activity

  3 years

Study Arms (1)

SetPoint System users

Patients indicated for the SetPoint System in whom the implant procedure for the SetPoint System has been attempted

Device: SetPoint System

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)

SetPoint System users

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients 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).

You may qualify if:

• Indicated for the SetPoint System
• Implant procedure for the SetPoint System has been attempted
• Willing to sign Informed Consent Form

You may not qualify if:

• Contraindicated for the SetPoint System

Sponsors & Collaborators

• SetPoint Medical Corporation: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Vickie Haines

CONTACT

661-750-6140; vhaines@setpointmedical.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 24, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: March 24, 2026

Record last verified: 2026-03