[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100434412":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":20,"id":51,"slug":20,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":20,"eligibilityCriteria":55,"healthyVolunteers":52,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":20,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Össur Iceland ehf","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single arm","EXPERIMENTAL","Single arm. All subjects will receive the intervention. Comparator device will be subjects' own prosthesis at baseline.",[13],"Device: IMES",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","IMES","Surgical implantation of IMES",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Aidan Roche, MD","NHS; University of Edinburgh","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Daire McGuinness, BSc","CONTACT","00441315070097","dmcguinness@ossur.com",[33],{"facility":34,"status":35,"city":36,"state":20,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"NHS Greater Glasgow and Clyde","RECRUITING","Glasgow","0000 000","United Kingdom","UK",{"type":41,"coordinates":42},"Point",[43,44],-4.25763,55.86515,{"lat":44,"lon":43},[47],{"name":48,"role":29,"phone":20,"phoneExt":20,"email":20},"Aidan Roche",{"type":50,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100434412",false,"NCT04936789","Clinical Feasibility of the IMES Transradial Prosthesis","Inclusion Criteria:\n\n* (unilateral acquired transradial) amputation\n* residual limb size requirements to fit investigational device componentry\n* at least 6 residual muscle locations available for implantation\n* good compliance with health service (rehabilitation)\n* willing to undergo surgical implantation of IMES Sensor implants\n* experience with myoelectric upper limb prostheses\n* using own myoelectric device approximately 6-8h\u002Fday\n* able to provide informed consent and attend the study visits\n\nExclusion Criteria:\n\n* any condition which in the opinion of the investigator poses a risk to health\n* neurological disorder that may prohibit accurate control\n* major injury proximal to the level of amputation\n* neuromuscular disorder\n* nerve transection or palsy that may cause de-innervation of muscles planned for implantation\n* allergy to implanted materials\n* existing active implant","ALL","18 Years","65 Years",{"count":60,"type":61},3,"ESTIMATED","INTERVENTIONAL",[64],"NA","This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control a transradial prosthesis",[67],"Amputation","2024-10-04",{"date":70,"type":71},"2024-10-08","ACTUAL",{"date":73,"type":71},"2023-01-01",{"date":75,"type":61},"2026-01",{"name":5,"class":6},1]