[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535030":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":20,"locations":26,"responsibleParty":44,"collaborators":46,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":7,"enrollmentInfo":59,"targetDuration":7,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":70,"overallStatus":29,"whyStopped":7,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Saint Francis Hospital","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DEVICE","Evoke","The Saluda Medical Evoke® CL-SCS System (Evoke System). The Evoke System measures and records spinal cord (SC) activation resulting from stimulation via evoked compound action potentials (ECAPs). The Evoke System can be programmed to provide ECAP-controlled, closed-loop SCS or open-loop, fixed-output (traditional) SCS; ECAPs may be measured and recorded in either stimulation mode.",[14],"Spinal Cord Stimulation",[16],{"name":17,"affiliation":18,"role":19},"Timothy Deer, MD","Spine and Nerve Center of Saint Francis Hospital","PRINCIPAL_INVESTIGATOR",[21],{"name":22,"role":23,"phone":24,"phoneExt":7,"email":25},"Amy Young, RN BSN DMPNA","CONTACT","304-347-6144","amelia.young3@wvumedicine.org",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"The Spine and Nerve Center of Saint Francis Hospital","RECRUITING","Charleston","West Virginia","25301","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-81.63262,38.34982,{"lat":39,"lon":38},[42],{"name":22,"role":23,"phone":43,"phoneExt":7,"email":25},"3043476144",{"type":45,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[47],{"name":48,"class":49},"Saluda Medical Americas, Inc.","INDUSTRY","100535030","real-world-efficacy-of-evoke-closed-loop-spinal-cord-stimulation-cl-scs-therapy-in-chronic-pain-patients-ultra-100535030",false,"NCT06246526","Real-World Efficacy of Evoke® Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy in Chronic Pain Patients (ULTRA).","ULTRA","Inclusion Criteria:\n\nBe 18 years of age or older at the time of enrollment.\n\nDiagnosed with chronic, intractable pain of the trunk and\u002For limbs, which has been refractory to conservative therapy for a minimum of 6 months.\n\nSubject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline.\n\nBe an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.\n\nBe willing and capable of giving informed consent.\n\nBe willing and able to comply with study-related requirements, procedures, and visits.\n\nExclusion Criteria:\n\nSubject is pregnant or nursing.\n\nHave a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator.\n\nHave evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and\u002For ability to evaluate treatment outcomes.\n\nHave an existing drug pump and\u002For SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).\n\nHave prior experience with SCS.\n\nBe concomitantly participating in another clinical study.","ALL","18 Years",{"count":60,"type":61},50,"ESTIMATED","INTERVENTIONAL",[64],"NA","This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.",[67,68,69],"Pain","Chronic Pain","Neuropathic Pain",[71,14],"Saluda","2026-06-22",{"date":74,"type":75},"2026-06-23","ACTUAL",{"date":77,"type":75},"2024-01-30",{"date":79,"type":61},"2027-12-31",{"name":5,"class":6},1]