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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P240039 / PAS001 |
| Date Original Protocol Accepted |
09/26/2025
|
| Date Current Protocol Accepted |
01/16/2026
|
| Study Name |
Safety and Performance PAS
|
| Device Name |
SetPoint System
|
| Clinical Trial Number(s) |
NCT04539964
|
| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: At least 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Design: Prospective, multicenter, observational post-market registry study with no investigational interventions. Objectives: (1) Assess adherence to surgical training requirements; (2) Monitor device performance including complaints and deficiencies/malfunctions; (3) Evaluate clinical outcomes as observed in routine practice; (4) Monitor safety outcomes including device-related adverse events as required by FDA Conditions of Approval.
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| Study Population |
Adult patients with moderately to severely active rheumatoid arthritis who are indicated for the SetPoint System and have attempted implant procedures. Inclusion: (1) Indicated for SetPoint System; (2) Implant procedure attempted; (3) Willing to sign informed consent. Exclusion: (1) Contraindicated for SetPoint System; (2) Enrolled in concurrent drug/device studies; (3) Life expectancy <3 years.
|
| Sample Size |
Number of subjects: Approximately 150 participants
Assumptions for sample size estimation: 90% power to detect adverse events occurring at =1.5% population rate; 98% power to demonstrate device failure rate <14% (assuming true rate of 5%); based on RESET-RA experience of 34/242 subjects with Charger deficiencies.
Number of sites: Multiple rheumatology sites (unspecified)
Sites location: United States
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| Key Study Endpoints |
Safety Endpoints - Primary: Related adverse events attributed to implantation/explantation procedures, SetPoint System components, or stimulation therapy
Safety Endpoints - Secondary: Device complaints and deficiencies; serious adverse events; device replacements due to cauterization or deficiencies.
Effectiveness Endpoints - Primary: None specified (observational study)
Effectiveness Endpoints - Secondary: Clinical Disease Activity Index (CDAI) assessments; device performance metrics (battery status, impedance, dose compliance).
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| Follow-up Visits and Length of Follow-up |
Schedule: Screening, implant procedure, post-operative clearance, activation (14-21 days post-surgery), then every 6 months for 3 years (visits at 6, 12, 18, 24, 30, and 36 months post-activation). Length: Maximum 3 years post-implant. Additional visits: Explant and post-explant clearance visits as needed; unscheduled visits for adverse events or device deficiencies.
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