[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630565":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":17,"studyPopulation":18,"armGroups":19,"interventions":25,"overallOfficials":13,"centralContacts":31,"locations":13,"responsibleParty":37,"collaborators":13,"id":39,"slug":13,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":13,"enrollmentInfo":48,"targetDuration":51,"studyType":52,"phases":13,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":61,"whyStopped":13,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":13},{"fullName":5,"class":6},"SetPoint Medical Corporation","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical Disease Activity Index (CDAI)","The CDAI score is based on 4 items:\n\n* Tender joint count of 28 joints (TJC28). Scale: 0=best to 28=worst\n* Swollen joint count of 28 joints (SJC28). Scale: 0=best to 28=worst\n* Subject global assessment (SGA). Scale: 0=best to 10=worst\n* Evaluator's global assessment (EGA). Scale: 0=best to 10=worst\n\nThe CDAI score is calculated as follows and ranges from 0 to 76:\n\n• CDAI = TJC28 + SJC28 + SGA + EGA\n\nThe CDAI score corresponds to the current RA activity:\n\n* 0 to ≤ 2.8 Remission\n* \\>2.8 to ≤ 10 Low disease activity (LDA)\n* \\>10 to ≤ 22 Moderate disease activity\n* \\> 22 High disease activity","3 years",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":15,"timePerspective":16,"maskingInfo":13},"CASE_ONLY","PROSPECTIVE","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.","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\u002FtsDMARDs).",[20],{"label":21,"type":13,"description":22,"interventionNames":23},"SetPoint System users","Patients indicated for the SetPoint System in whom the implant procedure for the SetPoint System has been attempted",[24],"Device: SetPoint System",[26],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":13},"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\u002FtsDMARDs)",[21],[32],{"name":33,"role":34,"phone":35,"phoneExt":13,"email":36},"Vickie Haines","CONTACT","661-750-6140","vhaines@setpointmedical.com",{"type":38,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100630565",false,"NCT07489326","The SetPoint System Safety & Performance Post-Approval Study","The SetPoint System Safety & Performance Post-Approval Study (ACTIVATE Study)","ACTIVATE","Inclusion Criteria:\n\n* Indicated for the SetPoint System\n* Implant procedure for the SetPoint System has been attempted\n* Willing to sign Informed Consent Form\n\nExclusion Criteria:\n\n* Contraindicated for the SetPoint System","ALL","22 Years",{"count":49,"type":50},150,"ESTIMATED","3 Years","OBSERVATIONAL","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.",[55],"Rheumatoid Arthritis",[55,57,58,59,60],"Vagus nerve","vagus nerve stimulating device","permanent implantable","implant","NOT_YET_RECRUITING","2026-03-19",{"date":64,"type":65},"2026-03-24","ACTUAL",{"date":67,"type":50},"2026-04-15",{"date":69,"type":50},"2031-01-01",{"name":5,"class":6}]