[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505091":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":25,"responsibleParty":45,"collaborators":11,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":28,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"University Hospital, Ghent","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NovaSure ablation","EXPERIMENTAL",null,[13],"Device: NovaSure ablation",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DEVICE","Ablation of the endometrial tissue using the NovaSure device",[9],[20],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Studies Vrouwenkliniek","CONTACT","+32 9 332 37 83","studieco.vrouwenkliniek@uzgent.be",[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Ghent University Hospital","RECRUITING","Ghent","East Flanders","9000","Belgium","BE",{"type":35,"coordinates":36},"Point",[37,38],3.71667,51.05,{"lat":38,"lon":37},[41],{"name":42,"role":22,"phone":43,"phoneExt":11,"email":44},"Study Coordinator","0032 9 332 07 58","gynobs.studies@uzgent.be",{"type":46,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100505091","novasure-study-endometrial-ablation-in-women-with-heavy-menstrual-bleeding-100505091",false,"NCT05856838","NovaSure Study: Endometrial Ablation in Women With Heavy Menstrual Bleeding","Radiofrequency Ablation in Women With Heavy Menstrual Bleeding, Procedure in an Outpatient Setting","RAMBOS","Inclusion Criteria:\n\n* ≥ 35 years - ≤ 50 years\n* Heavy menstrual bleeding (PBAC ≥ 150)\n* Unsuccessful drug treatment, contraindication to drug treatment or rejection of drug treatment by the patient\n* The absence of intra-uterine abnormalities on diagnostic hysteroscopy\n* Endometrial biopsy (pipelle) is normal\n* Finished childbearing\n\nExclusion Criteria:\n\n* Pregnancy\n* Endometritis\n* Adenomyosis\n* Contra-indication for local anaesthetics\n* Presence of severe systemic disease (≥ASA 3)\n* Previously performed endometrial ablation\n* Poor understanding of Dutch language\n* History of pelvic malignancy\n* Presence of an intra uterine device (IUD)\n* Cavity pathology (myoma, septum)\n* Cavity length \\\u003C 4 cm\n* Each uterine incision other than conventional caesarean incision","FEMALE","35 Years","50 Years",{"count":59,"type":60},30,"ESTIMATED","INTERVENTIONAL",[63],"NA","Heavy menstrual bleeding (HMB) affects 30% of women worldwide. It negatively influences physical activity, work productivity, sexual life and overall quality of life.\n\nIn 2018, the FIGO (International Federation of Gynaecology and Obstetrics) revised its definition of AUB (FIGO-AUB system 1) and the classification of the underlying causes (FIGO-AUB system 2). It includes HMB, which is a subjective parameter and therefore patient determined. The FIGO-AUB system 2 describes the underlying causes of AUB through the acronym PALM-COEIN: Polyps, Adenomyosis, Leiomyomatosis, Malignancy, Coagulopathy, Endometrial, Iatrogenic and not otherwise specified.\n\nThe National Institute for Health and Care Excellence (NICE) guideline on HMB recommends the levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg as the treatment of first choice in women with no identified pathology, fibroids less than 3cm in diameter, which are not causing distortion of the uterine cavity, or adenomyosis. If a woman declines a LNG-IUS, non-hormonal (fibrinolytics or non-steroidal anti-inflammatory drugs (NSAIDs)) and other hormonal pharmacological treatments can be considered. If treatment is unsuccessful, the woman declines pharmacological treatment, or symptoms are severe, an endometrial ablation (EA) or hysterectomy can be an alternative option. The latter is a definitive solution, but it is an invasive option, with a risk of serious complications.\n\nAn EA is a procedure that destroys the endometrium. It aims to reduce the menstrual flow, sometimes causing amenorrhea. Initially, it was performed through hysteroscopy. Later on, second-generation devices became available. NovaSure is an example of a second-generation EA device, using a bipolar radiofrequency impedance-controlled system that evaporates endometrial tissue. The EA procedure is a minimally invasive alternative to hysterectomy. It is known to result in amenorrhea in 50% of women, with satisfaction rates between 80-96% and reported reintervention rates around 10%. Moreover, it is feasible to perform the procedure using only local anaesthesia.\n\nThe investigators aim to assess the patient acceptability and feasibility of NovaSure EA in an outpatient setting with a short observation (≤4 hours)\n\nThis observational prospective cohort study will be performed in the Ghent University Hospital (Ghent), Leuven Catholic University Hospital (Leuven) and Turnhout General Hospital (Turnhout).\n\nThe surgeon performing the procedure will be the same per institution. The duration of the study is estimated at 4 months.",[66],"Menstrual Bleeding, Heavy",[68,69,70],"Menorrhagia\u002Fsurgery","Endometrial Ablation Techniques","Endometrium\u002Fsurgery","2025-12-18",{"date":73,"type":74},"2025-12-26","ACTUAL",{"date":76,"type":74},"2023-11-24",{"date":78,"type":60},"2026-12-31",{"name":5,"class":6},1]