A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial A… (NCT02029911) | Clinical Trial Compass
CompletedNot Applicable
A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORAâ„¢ Endometrial Ablation System
Canada63 participantsStarted 2011-06
Plain-language summary
This is a multi-center, single-arm, non-randomized, prospective clinical study. The clinical study is designed as a non-inferiority study to assess the effectiveness of the Aurora Endometrial Ablation System compared to an objective standard. Safety will be evaluated by determining the number and percentage of subjects who experience one or more of serious adverse events.
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