[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536821":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":101,"collaborators":103,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":112,"sex":117,"minAge":118,"maxAge":26,"enrollmentInfo":119,"targetDuration":26,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Universitaire Ziekenhuizen KU Leuven","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Temporary artery clipping","EXPERIMENTAL","Patients undergoing a robotically-assisted myomectomies, with temporary clipping of the uterine arteries and the utero-ovarian ligmants.",[13],"Procedure: Temporary clipping of the uterine arteries and the utero-ovarian ligmants.",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","Patients undergoing a robotically-assisted myomectomies, without temporary clipping of the uterine arteries and the utero-ovarian ligmants.",[19],"Procedure: No temporary clipping of the uterine arteries and the utero-ovarian ligmants.",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Temporary clipping of the uterine arteries and the utero-ovarian ligmants.","Temporary clipping of the uterine arteries and the utero-ovarian ligaments using laparoscopic clips\u002Fbulldog clamps, during robotically assisted myomectomy.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"No temporary clipping of the uterine arteries and the utero-ovarian ligmants.","Robotically assisted myomectomy, for which no temporary clipping of the uterine arteries and the utero-ovarian ligaments",[15],[32],{"name":33,"affiliation":5,"role":34},"Wouter Froyman, MD, PhD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Stefan Timmerman, MD","CONTACT","+3216348826","stefan.timmerman@uzleuven.be",{"name":33,"role":38,"phone":42,"phoneExt":26,"email":43},"+3216344202","wouter.froyman@uzleuven.be",[45,61,76,87],{"facility":46,"status":47,"city":48,"state":26,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"University Hospitals Leuven","RECRUITING","Leuven","3000","Belgium","BE",{"type":53,"coordinates":54},"Point",[55,56],4.70093,50.87959,{"lat":56,"lon":55},[59],{"name":33,"role":38,"phone":60,"phoneExt":26,"email":43},"+3216342612",{"facility":62,"status":63,"city":64,"state":26,"zip":26,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Department of Gynecology and Obstetrics, Hopital Bichat","NOT_YET_RECRUITING","Paris","France","FR",{"type":53,"coordinates":68},[69,70],2.3488,48.85341,{"lat":70,"lon":69},[73],{"name":74,"role":38,"phone":26,"phoneExt":26,"email":75},"Martin Koskas, MD, PhD","martin.koskas@aphp.fr",{"facility":77,"status":63,"city":78,"state":26,"zip":26,"country":65,"countryCode":66,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Service de gynécologie, Centre Hospitalier Universitaire de Rennes","Rennes",{"type":53,"coordinates":80},[81,82],-1.67431,48.11109,{"lat":82,"lon":81},[85],{"name":86,"role":38,"phone":26,"phoneExt":26,"email":26},"Vincent Lavoué, MD, PhD",{"facility":88,"status":63,"city":89,"state":26,"zip":26,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Amsterdam UMC, locatie VUmc","Amsterdam","Netherlands","NL",{"type":53,"coordinates":93},[94,95],4.88969,52.37403,{"lat":95,"lon":94},[98],{"name":99,"role":38,"phone":26,"phoneExt":26,"email":100},"Robert De Leeuw, MD, PhD","r.a.deleeuw@amsterdamumc.nl",{"type":102,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[104,106,108],{"name":105,"class":6},"Amsterdam UMC, location VUmc",{"name":107,"class":6},"Bichat Hospital",{"name":109,"class":6},"Rennes University Hospital","100536821","temporary-artery-clipping-for-robotically-assisted-myomectomy-a-multicentric-randomized-controlled-trial-100536821",false,"NCT06269809","Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial","TACROM","Inclusion Criteria:\n\nParticipants eligible for inclusion in this Trial must meet all of the following criteria:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n2. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.\n3. Female\n4. Age: 18-50 years\n5. Myomas, eligible for myomectomy, with the exclusion of FIGO 7-8 myomas.\n\nExclusion Criteria:\n\nParticipants eligible for this Trial must not meet any of the following criteria:\n\n1. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol\n2. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial\n3. Participation in an interventional Trial with an investigational medicinal product (IMP) or device\n4. Patient refusal to participate in the Trial\n5. (Possible) malignancy\n6. any contra indication for a laparoscopic or robotic surgery","FEMALE","18 Years",{"count":120,"type":121},82,"ESTIMATED","INTERVENTIONAL",[124],"NA","This study aims to investigate the efficacy of temporary clipping of the uterine artery and utero-ovarian ligament during robotically assisted myomectomy (RAM) for uterine fibroids. While RAM is increasingly used for myomectomy, bleeding control remains challenging. Temporary clipping of arteries has shown promise in conventional laparoscopy but has not been studied in RAM. This randomized controlled trial will assess primary endpoints such as estimated blood loss, need for transfusion, and hemoglobin drop, alongside secondary outcomes like complication rates and operation time.",[127],"Fibroid Uterus",[129,130,131,132,133,134],"myomectomy","fibroid","myoma","blood loss","temporary artery clipping","hemostatic measures","2025-03-11",{"date":137,"type":138},"2025-03-14","ACTUAL",{"date":140,"type":138},"2023-05-04",{"date":142,"type":121},"2025-05-30",{"name":5,"class":6},4]