A Single Arm Clinical Study of the Safety and Efficacy of the AURORAâ„¢ Endometrial Ablation System (NCT02023801) | Clinical Trial Compass
CompletedNot Applicable
A Single Arm Clinical Study of the Safety and Efficacy of the AURORAâ„¢ Endometrial Ablation System
Mexico24 participantsStarted 2011-08
Plain-language summary
This is a clinical study without a formal hypothesis. The primary objective of the study is to evaluate the use of the Aurora Endometrial Ablation System in achieving a return to normal menstrual blood loss at 12 months post-treatment, in premenopausal women with menorrhagia due to benign causes for whom childbearing is complete or no longer wish to retain fertility.
Who can participate
Age range25 Years – 50 Years
SexFEMALE
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Inclusion criteria
✓. Refractory menorrhagia with no definable organic cause
✓. Female subject from age 25 to 50 years
✓. Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
✓. One of the following criteria:
✓. Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
✓. Not pregnant and no desire to be pregnant in the future
✓. Patient agrees not to use hormonal contraception or any other medical intervention for bleeding during the study
✓. Able to provide written informed consent using a form that has been approved by the reviewing IRB/EC
Exclusion criteria
✕. Pregnancy or subject with a desire to conceive
✕. Endometrial hyperplasia as confirmed by histology
✕. Presence of active endometritis
✕. Active pelvic inflammatory disease
✕. Active sexually transmitted disease (STD), at the time of ablation. Note: Treatment of STD documented in the chart serves as sufficient evidence of infection resolution. Patient may be considered for study enrollment.
What they're measuring
1
Reduction in Menstrual Blood Loss to Normal Levels at 12 Months