Endometrial ablation for women with heavy menstrual bleeding
Official title: Radiofrequency Ablation in Women With Heavy Menstrual Bleeding, Procedure in an Outpatient Setting
Run by University Hospital, Ghent · NCT05856838 · Data updated 2026-11-12
This study is testing if a procedure called NovaSure can help women aged 35 to 50 with heavy menstrual bleeding find relief when medications haven't worked.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 35 Years to 50 Years |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent, East Flanders) |
| Status | Recruiting |
| Started | November 24, 2023 |
| Main results expected | January 1, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | December 26, 2025 |
| Trial ID | NCT05856838 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 35 to 50 with heavy menstrual bleeding who have not responded to or cannot use drug treatments.
✕Probably not a fit
Patients who are pregnant, have certain uterine abnormalities, or have a history of pelvic malignancy will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial focuses on women aged 35 to 50 who experience heavy menstrual bleeding (HMB) and have not found relief through medication. Participants will undergo a diagnostic hysteroscopy to rule out any intrauterine abnormalities, followed by the NovaSure ablation procedure to reduce menstrual bleeding. The study will assess the effectiveness of this intervention by measuring menstrual blood loss and collecting baseline characteristics. Participants will also receive support and pain management during the procedure.
Why it matters
Potential benefit: If successful, this procedure could significantly reduce heavy menstrual bleeding and improve the quality of life for affected women.
How similar studies have gone: Previous studies on endometrial ablation techniques have shown promising results in reducing heavy menstrual bleeding, indicating that this approach is supported by existing evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Ghent University Hospital
Ghent, East Flanders, Belgium Recruiting
Study contacts
- Study coordinator: Studies Vrouwenkliniek
- Email: studieco.vrouwenkliniek@uzgent.be
- Phone: +32 9 332 37 83
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.