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New treatment option for Menstrual Bleeding, Heavy
Official title NovaSure Study: Endometrial Ablation in Women With Heavy Menstrual Bleeding
ClinicalTrials.gov ID: NCT05856838
What this study is testing
- What it's testing
- Heavy menstrual bleeding (HMB) affects 30% of women worldwide. It negatively influences physical activity, work productivity, sexual life and overall quality of life.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 50, women only
You may be able to join if
- ≥ 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
You likely can't join if
- Pregnancy
- Endometritis
- Adenomyosis
- Contra-indication for local anaesthetics
- Presence of severe systemic disease (≥ASA 3)
- Previously performed endometrial ablation
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, East Flanders, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 35 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, East Flanders, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.