Nctid:
NCT06229470
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000059350", "term"=>"Chronic Pain"}], "ancestors"=>[{"id"=>"D000010146", "term"=>"Pain"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M29442", "name"=>"Chronic Pain", "asFound"=>"Chronic Pain", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4854", "name"=>"Benzocaine", "relevance"=>"LOW"}, {"id"=>"T433", "name"=>"Tannic Acid", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>250}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-03-08", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2027-02-28", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-24", "studyFirstSubmitDate"=>"2024-01-11", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-02-28", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System", "timeFrame"=>"through 6-months post-implant", "description"=>"physiological parameter to be measured = Evoked Compound Action Potentials (ECAPs); measurement tool = Evoke SCS System"}], "secondaryOutcomes"=>[{"measure"=>"Change in Visual Analogue Scale (VAS) Pain", "timeFrame"=>"through 6-months post-implant", "description"=>"Visual Analogue Scale (VAS) to rate pain intensity (0mm \\[no pain\\] to 100mm \\[worst pain imaginable\\])"}, {"measure"=>"Change in PROMIS-29+2", "timeFrame"=>"through 6-months post-implant", "description"=>"PROMIS-29 Profile and 2 PROMIS Cognitive Function Abilities items. The PROMIS-29 is a 29-item profile instrument that assesses 8 universal domains (not disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity."}, {"measure"=>"Change in PROMIS-10 Global Health", "timeFrame"=>"through 6-months post-implant", "description"=>"10-item instrument that assesses Physical Health and Mental Health"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"conditions"=>["Chronic Pain"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Subject is planning to have a temporary trial with the Evoke System to aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and/or intractable low back pain and leg pain.\n* Leg pain score ≥ 6 cm (Visual Analog Scale \\[VAS\\]).\n* Back pain score ≥ 6 cm (VAS).\n* Subject is able to speak, read, and/or understand English, willing and capable of giving informed consent, and able to comply with study-related requirements, procedures, and visits.\n* Subject is not pregnant and not \\<18 years of age.\n\nExclusion Criteria:\n\n* N/A"}, "identificationModule"=>{"nctId"=>"NCT06229470", "acronym"=>"Neural Panel", "briefTitle"=>"Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Saluda Medical Pty Ltd"}, "officialTitle"=>"A Prospective, Multicenter, Single-arm Study Evaluating the Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop Spinal Cord Stimulation (SCS) to Guide Treatment of Patients With Chronic Pain of the Trunk and/or Limbs.", "orgStudyIdInfo"=>{"id"=>"D103977"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"ECAP-Controlled, Closed-Loop SCS", "description"=>"Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.", "interventionNames"=>["Device: Evoke Spinal Cord Stimulation (SCS) System"]}], "interventions"=>[{"name"=>"Evoke Spinal Cord Stimulation (SCS) System", "type"=>"DEVICE", "description"=>"A spinal cord stimulation (SCS) system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.", "armGroupLabels"=>["ECAP-Controlled, Closed-Loop SCS"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"86403", "city"=>"Lake Havasu City", "state"=>"Arizona", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Lakeside Spine and Pain", "geoPoint"=>{"lat"=>34.4839, "lon"=>-114.32245}}, {"zip"=>"93010", "city"=>"Camarillo", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Spanish Hills Interventional Pain Specialists", "geoPoint"=>{"lat"=>34.21639, "lon"=>-119.0376}}, {"zip"=>"91942", "city"=>"La Mesa", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Pain Consultants of San Diego", "geoPoint"=>{"lat"=>32.76783, "lon"=>-117.02308}}, {"zip"=>"94104", "city"=>"Santa Rosa", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Pacific Research Institute", "geoPoint"=>{"lat"=>38.44047, "lon"=>-122.71443}}, {"zip"=>"94598", "city"=>"Walnut Creek", "state"=>"California", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Boomerang Healthcare", "geoPoint"=>{"lat"=>37.90631, "lon"=>-122.06496}}, {"zip"=>"80111", "city"=>"Greenwood Village", "state"=>"Colorado", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"DBPS Research", "geoPoint"=>{"lat"=>39.61721, "lon"=>-104.95081}}, {"zip"=>"33445", "city"=>"Delray Beach", "state"=>"Florida", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Pohlman Pain Associates", "geoPoint"=>{"lat"=>26.46146, "lon"=>-80.07282}}, {"zip"=>"30143", "city"=>"Jasper", "state"=>"Georgia", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Horizon Clinical Research", "geoPoint"=>{"lat"=>34.46787, "lon"=>-84.42909}}, {"zip"=>"61107", "city"=>"Rockford", "state"=>"Illinois", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Rockford Pain Center", "geoPoint"=>{"lat"=>42.27113, "lon"=>-89.094}}, {"zip"=>"46032", "city"=>"Carmel", "state"=>"Indiana", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Goodman Campbell Brain and Spine", "geoPoint"=>{"lat"=>39.97837, "lon"=>-86.11804}}, {"zip"=>"50317", "city"=>"Des Moines", "state"=>"Iowa", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Metro Anesthesia & Pain Management", "geoPoint"=>{"lat"=>41.60054, "lon"=>-93.60911}}, {"zip"=>"40241", "city"=>"Louisville", "state"=>"Kentucky", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Restorative Pain Institute", "geoPoint"=>{"lat"=>38.25424, "lon"=>-85.75941}}, {"zip"=>"70403", "city"=>"Hammond", "state"=>"Louisiana", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Advanced Pain Institute", "geoPoint"=>{"lat"=>30.50463, "lon"=>-90.46293}}, {"zip"=>"21061", "city"=>"Glen Burnie", "state"=>"Maryland", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Spine and Joint Institute", "geoPoint"=>{"lat"=>39.16261, "lon"=>-76.62469}}, {"zip"=>"48108", "city"=>"Ann Arbor", "state"=>"Michigan", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Michigan Pain Specialists", "geoPoint"=>{"lat"=>42.27756, "lon"=>-83.74088}}, {"zip"=>"48309", "city"=>"Rochester Hills", "state"=>"Michigan", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Pain Clinic of Michigan", "geoPoint"=>{"lat"=>42.65837, "lon"=>-83.14993}}, {"zip"=>"68803", "city"=>"Grand Island", "state"=>"Nebraska", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Tricity Research Center, LLC", "geoPoint"=>{"lat"=>40.92501, "lon"=>-98.34201}}, {"zip"=>"89509", "city"=>"Reno", "state"=>"Nevada", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Reno Tahoe Pain Associates", "geoPoint"=>{"lat"=>39.52963, "lon"=>-119.8138}}, {"zip"=>"07013", "city"=>"Clifton", "state"=>"New Jersey", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Garden State Pain and Orthopedics", "geoPoint"=>{"lat"=>40.85843, "lon"=>-74.16376}}, {"zip"=>"28412", "city"=>"Wilmington", "state"=>"North Carolina", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Seaside Clinical Research Institute", "geoPoint"=>{"lat"=>34.22573, "lon"=>-77.94471}}, {"zip"=>"44195", "city"=>"Cleveland", "state"=>"Ohio", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Cleveland Clinic Foundation", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"zip"=>"45140", "city"=>"Loveland", "state"=>"Ohio", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Premier Pain Treatment Institute", "geoPoint"=>{"lat"=>39.26895, "lon"=>-84.26383}}, {"zip"=>"29615", "city"=>"Greenville", "state"=>"South Carolina", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Carolinas Center for Advanced Management of Pain", "geoPoint"=>{"lat"=>34.85262, "lon"=>-82.39401}}, {"zip"=>"77904", "city"=>"Victoria", "state"=>"Texas", "status"=>"RECRUITING", "country"=>"United States", "facility"=>"Victoria Pain and Rehabilitation Center", "geoPoint"=>{"lat"=>28.80527, "lon"=>-97.0036}}], "centralContacts"=>[{"name"=>"Angela Leitner, MS", "role"=>"CONTACT", "email"=>"angela.leitner@saludamedical.com", "phone"=>"651-208-4223"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Saluda Medical Pty Ltd", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
