[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493217":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":45,"studyPopulation":45,"armGroups":52,"interventions":62,"overallOfficials":45,"centralContacts":68,"locations":79,"responsibleParty":97,"collaborators":99,"id":102,"slug":103,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":45,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":82,"whyStopped":45,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":45},[9],{"measure":10,"description":11,"timeFrame":12},"Positioning of the ReLARC IUD","To evaluate the position of the ReLARC® IUD to confirm the succesful placement of the IUD with the ReLARC inserter during every follow-up visit.","3 years",[14,18,21,24,28,32,36,39,42],{"measure":15,"description":16,"timeFrame":17},"Ease of insertion","1\\. The ease of the insertion (hysteroscope and ReLARC® device) by the following scale:\n\n1. Insertion went smoothly.\n2. I had little trouble while inserting the device but experienced this as a not important delay in my surgical act.\n3. Insertion was rather difficult.\n4. Insertion was time consuming, difficult, and dangerous.\n5. Insertion was not possible due to technical issues or medical reasons.","During Insertion visit",{"measure":19,"description":20,"timeFrame":17},"Learning curve of ReLARC insertion","2\\. The learning curve of ReLARC® insertion, that starts after introducing the scope in the cervix and ends when the thread is cut and looped. This will be reported in minutes.",{"measure":22,"description":23,"timeFrame":17},"Pain score","the participant's pain by a Visual Analogue Scale-VAS (1. no pain, 2. mild pain, 3. nasty pain, 4. severe pain, 5. unbearable pain) will be described.",{"measure":25,"description":26,"timeFrame":27},"patient satisfactory","The patient satisfactory score will be determined at every follow-up visit (4-8 weeks after insertion; 1 year after insertion, 2 years after insertion and 3 years after insertion)","3 years after insertion",{"measure":29,"description":30,"timeFrame":31},"Uterine cavity transverse diameter","the uterine cavity transverse diameter (UCTD) (before ReLARC® device insertion) will be described.","During insertion visit",{"measure":33,"description":34,"timeFrame":35},"Expulsion rate","The number of expulsions of the IUD will be registered during the trial","7 years",{"measure":37,"description":38,"timeFrame":35},"Removal rate","The number of early removal of the IUD will be registered during the trial",{"measure":40,"description":41,"timeFrame":35},"Ease of removal","The ease of removal (Likert scale): 1. very easy, 2. easy, 3. neither easy nor difficult, 4. difficult, 5. very difficult",{"measure":43,"description":44,"timeFrame":35},"Pain at removal","pain (VAS): 1. no pain, 2. mild pain, 3. nasty pain, 4. severe pain, 5. unbearable pain",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":45,"primaryPurpose":49,"observationalModel":45,"timePerspective":45,"maskingInfo":50},"NON_RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":51,"maskingDescription":45,"whoMasked":45},"NONE",[53,58],{"label":54,"type":6,"description":55,"interventionNames":56},"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).",[57],"Device: ReLARC",{"label":59,"type":6,"description":60,"interventionNames":61},"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).",[57],[63],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":45},"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.",[59,54],[69,75],{"name":70,"role":71,"phone":72,"phoneExt":73,"email":74},"Steven Weyers, MD","CONTACT","93327817","0032","steven.weyers@uzgent.be",{"name":76,"role":71,"phone":77,"phoneExt":73,"email":78},"Eline Meireson, Msc","09 332 78 17","eline.meireson@uzgent.be",[80],{"facility":81,"status":82,"city":83,"state":45,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"University Hospital","RECRUITING","Ghent","9000","Belgium","BE",{"type":88,"coordinates":89},"Point",[90,91],3.71667,51.05,{"lat":91,"lon":90},[94],{"name":95,"role":71,"phone":96,"phoneExt":45,"email":78},"Eline Meireson","+32 9 332 78 17",{"type":98,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR",[100],{"name":101,"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.","ReLARC - REL-0","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":114,"type":115},120,"ESTIMATED","INTERVENTIONAL",[118],"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.",[121],"Contraception",[123,124],"copper intra-uterine device","Hysteroscope","2026-09-16",{"date":127,"type":128},"2026-09-21","ACTUAL",{"date":130,"type":128},"2022-05-01",{"date":132,"type":115},"2027-12-31",{"name":5,"class":6},1]