[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536437":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":67,"collaborators":26,"id":69,"slug":26,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":26,"enrollmentInfo":78,"targetDuration":26,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Thuasne","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group : compressive bandaging","ACTIVE_COMPARATOR","Control group : compressive bandaging:\n\n* Intensive phase (3 weeks): compressive bandaging (day and night-time) according to the usual practice\n* Maintenance phase (5 weeks): usual compression sleeve during the day + Self bandages at night",[13],"Device: Compressive bandaging",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention group: MOBIDERM Autofit Armsleeve","EXPERIMENTAL","Intervention group: MOBIDERM Autofit Armsleeve\n\n* Intensive phase (3 weeks): MOBIDERM Autofit Armsleeve (day and night-time)\n* Maintenance phase (5 weeks): usual compression sleeve during the day + MOBIDERM Autofit Armsleeve at night",[19],"Device: MOBIDERM Autofit Armsleeve",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","MOBIDERM Autofit Armsleeve","In the intervention group, during the intensive phase, patients wear day and night MOBIDERM AUTOFIT during 3 weeks.\n\nDuring the maintenance phase, patients wear usual compression sleeve during the day and MOBIDERM Autofit Armsleeve at night during 5 weeks",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Compressive bandaging","In the control group, during the intensive phase, patients wear compressive bandaging day and night-time, according to the usual practice during 3 weeks.\n\nDuring the maintenance phase, patients wear usual compression sleeve during the day and self bandages at night during 5 weeks",[9],[32],{"name":33,"affiliation":34,"role":35},"Burcu DUYUR ÇAKIT","Ankara Training and Research Hospital Turkey","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Burcu DUYUR ÇAKIT, MD","CONTACT","0533 654 24 55","burcudcakit@gmail.com",{"name":43,"role":39,"phone":44,"phoneExt":26,"email":45},"ASTRID PICOLET","0640392490","astrid.picolet@thuasne.fr",[47,60],{"facility":48,"status":49,"city":50,"state":26,"zip":26,"country":51,"countryCode":26,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"ANKARA","RECRUITING","Ankara","Turkey (Türkiye)",{"type":53,"coordinates":54},"Point",[55,56],32.85427,39.91987,{"lat":56,"lon":55},[59],{"name":33,"role":39,"phone":26,"phoneExt":26,"email":26},{"facility":61,"status":49,"city":50,"state":26,"zip":26,"country":51,"countryCode":26,"cosmosGeoPoint":62,"geoPoint":64,"contacts":65},"Pinar BORMAN",{"type":53,"coordinates":63},[55,56],{"lat":56,"lon":55},[66],{"name":61,"role":39,"phone":26,"phoneExt":26,"email":26},{"type":68,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100536437",false,"NCT06264817","Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema.","A Multicenter, Single-blinded, Randomized Controlled Study to Assess the Efficacy of Auto-Adjustable MOBIDERL Autofit Armsleeve in the Management of Upper Limb Lymphedema. (LyberT)","LyberT","Inclusion Criteria:\n\n* Unilateral secondary upper limb lymphedema of stage II or III according to the criteria defined by the International Society of Lymphology, following breast cancer\n* Volume difference between affected and healthy arm ≥ 10%\n* Affected arm that fits with one of the 6 standard sizes of the Auto- Adjustable MOBIDERM Autofit armsleeve provided.\n* Signed informed consent prior to any study-mandated procedure.\n\nExclusion Criteria:\n\n* Stage I lymphedema or located in several places.\n* Patients for whom compression is contraindicated.\n* Lymphedema associated with active cancer needing acute chemotherapy or having recurrence or metastasis.\n* Motor and sensitive neurological deficiency \u002F psychiatric or addictive disorders\n* Pregnant or breastfeeding patient\n* Patient intolerant to MOBIDERM Autofit or known allergies to the components used.\n* Participation to any other clinical study which has an impact on the different endpoints\n* Vulnerable patient, adults being the object of a legal protective measure or enable to express their consent.","FEMALE","18 Years",{"count":79,"type":80},40,"ESTIMATED","INTERVENTIONAL",[83],"NA","This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema",[86],"Lymphedema of Upper Limb",[88,89,90],"Lymphedema of upper limb","Compression garments","lymphedema management","2024-09-20",{"date":93,"type":94},"2024-09-23","ACTUAL",{"date":96,"type":94},"2024-03-15",{"date":98,"type":80},"2025-04-15",{"name":5,"class":6},2]