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NovaSure Study: Endometrial Ablation in Women With Heavy Menstrual Bleeding

RecruitingNAAges 35 Years - 50 YearsFemaleUniversity Hospital, Ghent
NCT05856838 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Heavy menstrual bleeding (HMB) affects 30% of women worldwide. It negatively influences physical activity, work productivity, sexual life and overall quality of life. In 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. The 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

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📋 Eligibility rules (as published)
Inclusion Criteria: * ≥ 35 years - ≤ 50 years * Heavy menstrual bleeding (PBAC ≥ 150) * Unsuccessful drug treatment, contraindication to drug treatment or rejection of drug treatment by the patient * The absence of intra-uterine abnormalities on diagnostic hysteroscopy * Endometrial biopsy (pipelle) is normal * Finished childbearing Exclusion Criteria: * Pregnancy * Endometritis * Adenomyosis * Contra-indication for local anaesthetics * Presence of severe systemic disease (≥ASA 3) * Previously performed endometrial ablation * Poor understanding of Dutch language * History of pelvic malignancy * Presence of an intra uterine device (IUD) * Cavity pathology (myoma, septum) * Cavity length \< 4 cm * Each uterine incision other than conventional caesarean incision
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What it tests

  • NovaSure ablation
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Where

1 site
Ghent University Hospital
Ghent, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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