[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578283":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":22,"responsibleParty":86,"collaborators":88,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":10,"enrollmentInfo":102,"targetDuration":10,"studyType":105,"phases":10,"briefSummary":106,"conditions":107,"keywords":111,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"DJO UK Ltd","INDUSTRY",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"TENS\u002FUS group",null,"Patient affected by acute or chronic musculoskeletal pain or affected by post-operative pain that will be treated with TENS alone, US alone or TENS + US according to the current standard clinical practice at site.\n\nData from patients in this group will be used to determine the primary study objective, some of the exploratory objectives and the safety objectives.",{"label":13,"type":10,"description":14,"interventionNames":10},"NMES group","Patients affected by skeletal muscle deficit disorders who benefit form muscle re-education and\u002For maintaining\u002Fincreasing the range of motion will be treated with NMES alone or NMES + US according to the current standard clinical practice at site.\n\nData from patients in this group will be used to determine the secondary study objective, some of the exploratory objectives and the safety objectives",[16],{"name":17,"role":18,"phone":19,"phoneExt":20,"email":21},"Elena Arcangeli","CONTACT","3498772528","0039","elena.arcangeli@enovis.com",[23,35,53,69],{"facility":24,"status":25,"city":26,"state":10,"zip":10,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":10},"Attal Cabinet","COMPLETED","Serris","France","FR",{"type":30,"coordinates":31},"Point",[32,33],2.78611,48.84528,{"lat":33,"lon":32},{"facility":36,"status":37,"city":38,"state":10,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":46,"contacts":47},"Casertafisio","RECRUITING","Caserta","81100","Italy","IT",{"type":30,"coordinates":43},[44,45],14.33231,41.07262,{"lat":45,"lon":44},[48],{"name":49,"role":18,"phone":50,"phoneExt":51,"email":52},"Gian Paolo Papiro, Physiotherap","0823 321630","+39","g.papiro@gmail.com",{"facility":54,"status":37,"city":55,"state":10,"zip":56,"country":40,"countryCode":41,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Rachis Center","Roma","00199",{"type":30,"coordinates":58},[59,60],11.10642,44.99364,{"lat":60,"lon":59},[63,66],{"name":64,"role":18,"phone":10,"phoneExt":10,"email":65},"Stamatios Liaskos, Medical Dr.","stamatiosliaskos@gmail.com",{"name":67,"role":68,"phone":10,"phoneExt":10,"email":10},"Stamatios Liaskos","PRINCIPAL_INVESTIGATOR",{"facility":70,"status":37,"city":71,"state":10,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Dr Chad Woods Physiotherapy","Peebles","EH45","United Kingdom","UK",{"type":30,"coordinates":76},[77,78],-3.1888,55.6519,{"lat":78,"lon":77},[81],{"name":82,"role":18,"phone":83,"phoneExt":84,"email":85},"Chad Wood, Physiotherap","0794 339 8954","0044","drwoodsphysio@gmail.com",{"type":87,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[89],{"name":90,"class":91},"Donawa Lifescience Consulting SRL","UNKNOWN","100578283","observational-prospective-pmcf-study-to-confirm-performance-and-safety-of-intelect-devices-in-real-world-100578283",false,"NCT06809283","Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World","Observational Prospective Post Market Clinical Follow-up (PMCF) Study to Confirm the Performance and Safety of the Chattanooga Intelect® Devices in Real World Use","INTELECT","Inclusion Criteria:\n\n1. Patients with musculoskeletal and skeletal muscle deficit disorders assigned to be treated with any of the Intelect® devices according to the current clinical practice at the selected sites and based on the opinion of the Investigator.\n2. Patient male or female with age ≥18 years old.\n3. Patient able to provide written informed consent. For France only: To be affiliated to the social security system or to be beneficiary of such system\n\nExclusion Criteria:\n\n1. Patients participating in another clinical study or who have completed a clinical study less than 30 days prior to enrollment.\n2. Patients who for any reason e.g. significant co-morbidities or other reasons, are considered by the Investigator unsuitable for study participation.","ALL","18 Years",{"count":103,"type":104},144,"ESTIMATED","OBSERVATIONAL","DJO UK Ltd (ENOVIS) is conducting this study to confirm the performance and safety of the Chattanooga Intelect® devices in real world use. This study will record post market clinical data on the use of a number of MDR-CE marked devices that are part of the Chattanooga Intelect® device family to ensure the continued acceptability of the benefit-risk ratio, and to identify possible systematic misuse or off-label use of the devices (Intelect® Mobile 2 Combo, Intelect® Mobile 2 Ultrasound, Intelect® Mobile 2 Electrotherapy (Stim), Intelect® Transport 2 Combo and Intelect® Transport 2 Ultrasound).",[108,109,110],"Musculoskeletal Disorders","Skeletal Disorder","Muscle Disorder",[112,113,114,115,116],"TENS","NMES","Ultrasound","Pain","ROM","2025-11-14",{"date":119,"type":120},"2025-11-17","ACTUAL",{"date":122,"type":120},"2025-03-10",{"date":124,"type":104},"2026-12",{"name":5,"class":6},4]