[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493217":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":24,"locations":35,"responsibleParty":53,"collaborators":55,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":62,"acronym":20,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":23,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":38,"whyStopped":23,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"ReLARC 3","ReLARC® is a GyneFix® device intended to be inserted via hysteroscopy. Hysteroscopic insertion of the device allows direct visualization of the procedure, which makes it extremely safe.\n\nReLARC® 3 is inserted through a hysteroscope (KARL STORZ HOPKINS® Wide Angle Straight Forward Telescope 6°, art. no. 26208AMA in combination with the irrigation pump Endomat® select).",[12],"Device: ReLARC",{"label":14,"type":6,"description":15,"interventionNames":16},"ReLARC 10","ReLARC® is a GyneFix® device intended to be inserted via hysteroscopy. Hysteroscopic insertion of the device allows direct visualization of the procedure, which makes it extremely safe.\n\nReLARC® 10 is inserted through a hysteroscope (KARL STORZ HOPKINS® Wide Angle Straight Forward Telescope 6°, art. no. 26208AMA in combination with the irrigation pump Endomat® select).",[12],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","ReLARC","ReLARC® is a GyneFix® device intended to be inserted via hysteroscopy. Hysteroscopic insertion of the device allows direct visualization of the procedure, which makes it extremely safe.",[14,9],null,[25,31],{"name":26,"role":27,"phone":28,"phoneExt":29,"email":30},"Steven Weyers, MD","CONTACT","93327817","0032","steven.weyers@uzgent.be",{"name":32,"role":27,"phone":33,"phoneExt":29,"email":34},"Eline Meireson, Msc","09 332 78 17","eline.meireson@uzgent.be",[36],{"facility":37,"status":38,"city":39,"state":23,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University Hospital","RECRUITING","Ghent","9000","Belgium","BE",{"type":44,"coordinates":45},"Point",[46,47],3.71667,51.05,{"lat":47,"lon":46},[50],{"name":51,"role":27,"phone":52,"phoneExt":23,"email":34},"Eline Meireson","+32 9 332 78 17",{"type":54,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[56],{"name":57,"class":6},"Federico II University","100493217","evaluation-of-the-safety-and-efficacy-of-the-relarc-inserter-during-the-insertion-procedure-of-gynefix-intrauterine-copper-bearing-contraceptive-device-with-a-follow-up-of-3-years-100493217",false,"NCT05702281","Evaluation of the Safety and Efficacy of the ReLARC Inserter During the Insertion Procedure of GYNEFIX Intrauterine Copper Bearing Contraceptive Device with a Follow-up of 3 Years.","Inclusion Criteria:\n\n* Generally healthy women, 18 - 48 years of age and not having a contraindication for hysteroscopy\n* Be willing to come back for the follow-ups\n* Be willing to refrain from having intercourse the first two weeks and using tampons and menstrual cups in the first 2 months, following insertion\n* Sign a written informed consent\n* Fundus thickness should be 11mm or more\n\nExclusion Criteria:\n\n* T and Y shaped uterus\n* U1, dysmorphic uterus (abnormal myometrium may result in bad device fixation)\n* Complete septate U2b uterus\n* Bicorporal U3-U6 uterus\n* Injectables contraceptive use in the last 6 months\n* The presence of infection of the uterus, clinical cervicitis or vaginitis (infection should be ruled out)\n* Intrauterine fibroids (intra-mural, intracavitary or submucosal)\n* Cancer or other disease of the uterus\n* Malignancy, or treatment for malignancy. Melanoma or any gynaecological cancer at any time excludes the subject\n* Blood clotting disorders\n* Intrauterine polyps\n* Subjects receiving corticosteroid therapy or immunosuppressive drugs\n* Morbus Wilson\n* AIDS\n* Pregnancy",true,"FEMALE","18 Years","48 Years",{"count":69,"type":70},120,"ESTIMATED","INTERVENTIONAL",[73],"NA","Insertion under vision such as hysteroscopy allows the ability to visualize the uterus prior to insertion, to assess uterine compatibility and the assurance of proper device placement. ReLARC® is a GyneFix® device intended to be inserted via hysteroscopy. Hysteroscopic insertion of the device allows direct visualization of the procedure, which makes it extremely safe.\n\nThis multicentre, open-label study will take place at the Women's Clinic of Ghent University Hospital in Belgium (International Coordinating Centre) and at the University Hospital AOU Federico II of Naples in Italy.\n\nPrimary aim:\n\nTo evaluate the safety of the ReLARC® inserter during the insertion procedure of GyneFix® intrauterine copper bearing contraceptive devices by means of successful placement with adequate position during follow-up evaluations.\n\nProviding no complications develop, participants will remain in the study for 3 years. 120 women will be enrolled.",[76],"Contraception",[78,79],"copper intra-uterine device","Hysteroscope","2025-01-22",{"date":82,"type":83},"2025-01-27","ACTUAL",{"date":85,"type":83},"2022-05-01",{"date":87,"type":70},"2027-12-31",{"name":5,"class":6},1]