Endometrial ablation for women with heavy menstrual bleeding
Radiofrequency Ablation in Women With Heavy Menstrual Bleeding, Procedure in an Outpatient Setting
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 35 Years to 50 Years |
| Sex | Female |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent, East Flanders) |
| Trial ID | NCT05856838 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 35 to 50 with heavy menstrual bleeding who have not responded to or cannot use drug treatments.
Not a fit: Patients who are pregnant, have certain uterine abnormalities, or have a history of pelvic malignancy will not benefit from this study.
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 performed: Previous studies on endometrial ablation techniques have shown promising results in reducing heavy menstrual bleeding, indicating that this approach is supported by existing evidence.
Eligibility criteria
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 this trial is running
Ghent, East Flanders
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.