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NovaSure Study: Endometrial Ablation in Women With Heavy Menstrual Bleeding

NCT05856838 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-26

No results posted yet for this study

Summary

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 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.

An 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.

The investigators aim to assess the patient acceptability and feasibility of NovaSure EA in an outpatient setting with a short observation (≤4 hours)

This observational prospective cohort study will be performed in the Ghent University Hospital (Ghent), Leuven Catholic University Hospital (Leuven) and Turnhout General Hospital (Turnhout).

The surgeon performing the procedure will be the same per institution. The duration of the study is estimated at 4 months.

Conditions

  • Menstrual Bleeding, Heavy

Interventions

DEVICE

NovaSure ablation

Ablation of the endometrial tissue using the NovaSure device

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-24
Primary Completion
2026-01-01
Completion
2026-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05856838 on ClinicalTrials.gov