A Two-Phase Clinical Study of the Minerva AURORA Ablation System (NCT02035332) | Clinical Trial Compass
CompletedNot Applicable
A Two-Phase Clinical Study of the Minerva AURORA Ablation System
Hungary23 participantsStarted 2011-05
Plain-language summary
The primary objective of this study is to evaluate the use of the Aurora Ablation System in reducing menstrual blood loss at 12 months post-treatment. The occurrence of adverse events will be assessed along with an assessment of the reduction of uterine bleeding as measured by a pictorial blood loss assessment chart (PBLAC) or menstrual diary.
Who can participate
Age range35 Years – 50 Years
SexFEMALE
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Inclusion criteria
✓. Refractory menorrhagia with no definable organic cause (abnormal uterine bleeding)
✓. Female subject from age 35 to 50 years
✓. Uterine sound measurement of 6.0cm to 10.0cm (external os to internal fundus)
✓. A minimum PBLAC score of \>150 for 3 months prior to study enrollment; OR, A minimum PBLAC score \>150 for one month for women who either
✓. had at least 3 prior months documented failed medical therapy; or
✓. had a contraindication to medical therapy; or
✓. refused medical therapy
✓. Premenopausal at enrollment as determined by FSH measurement ≤ 40 IU/ml
Exclusion criteria
✕. Pregnancy or subject with a desire to conceive
✕. Complex endometrial hyperplasia as confirmed by histology
✕. Presence of active endometritis
✕. Active pelvic inflammatory disease
✕. Active sexually transmitted disease (STD)
✕. Presence of bacteremia, sepsis, or other active systemic infection
What they're measuring
1
Reduction in Menstrual Blood Loss to Normal Levels at 12-months