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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Ablation of the endometrial lining of the uterus using the Aurora System
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada
La Cite Medicale
Québec, Quebec, Canada
Hôpital Lasalle
Ville Lassalle, Quebec, Canada
Reduction in Menstrual Blood Loss to Normal Levels at 12 Months
Number of subjects in whom menstrual blood loss was reduced to normal or below normal levels at 12 months, as measured by a pictorial blood loss assessment chart (PBLAC) score of \<=75.
Time frame: 12 Months
Procedure Time
Procedure Time defined as time from insertion of the Disposable Handpiece to the time of removal.
Time frame: < 1 hour
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