[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557041":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":37,"centralContacts":44,"locations":51,"responsibleParty":71,"collaborators":49,"id":73,"slug":49,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":49,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":49,"enrollmentInfo":81,"targetDuration":49,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":98,"overallStatus":54,"whyStopped":49,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Maastricht University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lymphaticovenous anastomosis using Microsure Motion Stabilizer","EXPERIMENTAL","Patients in this group undergo robot-assisted lymphaticovenous anastomosis at one or more locations on the affected arm. The procedure is performed under local anesthesia. Incisions are made at the sites where lymphatic vessels are obstructed, ensuring no harm to the viable part of the lymphatic system. The location(s) are determined prior to surgery using ICG lymphography. LVA(s) are made in the subdermal plane with the aid of a surgical microscope. Generally, 1 to 4 LVAs are made. The LVAs are madeusing a surgical microscope and the operation takes approximately 240 minutes.",[13],"Device: Lymphaticovenous anastomosis using Microsure Motion Stabilizer",{"label":15,"type":16,"description":17,"interventionNames":18},"Lymphaticovenous anastomosis","ACTIVE_COMPARATOR","Patients in this group undergo lymphaticovenous anastomosis at one or more locations on the affected arm. The procedure is performed under local anesthesia. Incisions are made at the sites where lymphatic vessels are obstructed, ensuring no harm to the viable part of the lymphatic system. The location(s) are determined prior to surgery using ICG lymphography. LVA(s) are made in the subdermal plane with the aid of a surgical microscope. Generally, 1 to 4 LVAs are made. The LVAs are madeusing a surgical microscope and the operation takes approximately 90 minutes.",[19],"Procedure: Lymphaticovenous anastomosis (manual)",[21,31],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","The robot-assisted LVA is performed using the Microsure Motion Stabilizer, a telemanipulation tool that stabilizes a surgeon's movement during open microsurgical operations on extremities, specifically on veins and nerves that are close to the skin.\n\nThe surgeon controls a joystick, which directly copies the surgeon's movements in real-time to an instrument held by the device. The device's software scales down the motions and filters out tremor. Surgical technique and method of treatment are identical to conventional microsurgery. The device is equipped with genuine microsurgical instruments and is compatible with existing surgical microscopes. Instead of holding the instrument directly in hand, which is limited in precision and dexterity, the surgeon operates while the instrument's movements are stabilized. The modular design allows the surgeon to decide what level of manipulation assistance is required during a certain procedure.",[9],[26,27,28,29,30],"LVA","Lympahticovenular anastomosis","Lymphovenous bypass","Lymphatic-venous shunt","Robot-assisted LVA",{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"PROCEDURE","Lymphaticovenous anastomosis (manual)","Lymphaticovenous anastomosis (LVA) involves connecting a lymphatic vessel to an adjacent vein of similar size, thereby facilitating the outflow of lymphatic fluid in patients suffering from secondary lymphedema",[15],[26,15,28,29],[38,41],{"name":39,"affiliation":5,"role":40},"Shan Shan Qiu Shao, MSc, PhD","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":5,"role":43},"Tom van Mulken, MSc","STUDY_CHAIR",[45],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Alieske Kleeven, MSc","CONTACT","+31(0)433877481",null,"alieske.kleeven@mumc.nl",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Maastricht University Medical Center+","RECRUITING","Maastricht","Limburg","6229HX","Netherlands","NL",{"type":61,"coordinates":62},"Point",[63,64],5.68889,50.84833,{"lat":64,"lon":63},[67,68,69],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},{"name":39,"role":40,"phone":49,"phoneExt":49,"email":49},{"name":42,"role":70,"phone":49,"phoneExt":49,"email":49},"SUB_INVESTIGATOR",{"type":72,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100557041",false,"NCT06532955","The Robot-LVA Study: Robot-assisted Microsurgical Lymphaticovenous Anastomosis in Breast Cancer-related Lymphedema","Pilot Study on Robotic Assisted Microsurgical Lymphatico-venular Anastomosis","Inclusion Criteria:\n\n* Female gender;\n* Treated for primary early stage breast cancer;\n* Early stage lymphedema of the arm (stage 1 or 2 on ISL classification);\n* ELV \\> 10%;\n* Suffering from unilateral disease.\n\nExclusion Criteria:\n\n* Male gender;\n* Stage 3 lymphedema of the arm;\n* Receiving current breast cancer treatment;\n* Distant breast cancer metastases;\n* Current substance abuse;\n* History of marcaine or indocyanine green allergy;\n* Non-viable lymphatic system as determined by near infrared imaging;\n* Previous LVA (\\\u003C10 years) in the arm with lymphedema.","FEMALE","18 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"NA","This study assesses the performance of robot-assisted microsurgery. Lymphaticovenous anastomosis (LVA) is the most difficult procedure in microsurgery at this moment. The LVA technique is applied to treat for example breast cancer-related lymphedema (BCRL). Therefore, this LVA procedure is compared using a manual expert and the same expert applying robot-assisted LVA.",[89,90,91,92,93,94,95,96,97],"Lymphedema","Lymphedema Arm","Lymphedema of Upper Arm","Lymphedema of Upper Limb","Lymphedema; Surgical","Lymphedema, Secondary","Lymphedema of Limb","Lymphedema, Breast Cancer","Lymphedema, Non-Filarial",[99,100,101,102,103,15,104,26],"Robot-assisted microsurgery","Microsurgery","Robot","Robotic-assisted","Robot-assisted","Lymphatico-venular anastomosis","2024-07-30",{"date":107,"type":108},"2024-08-01","ACTUAL",{"date":110,"type":108},"2017-06-01",{"date":112,"type":83},"2026-01-01",{"name":5,"class":6},1]