At a glance
ClinicalIndex Comparison RecordN/ACompleted· 63 enrolled
Drug / intervention
Aurora Endometrial Ablation Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System
In Brief
A clinical study evaluating Aurora Endometrial Ablation System for Menorrhagia Due to Benign Causes. Completed, enrolled 63 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMenorrhagia Due to Benign Causes
CountriesCanada
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2011
Primary CompletionNov 2012
First PostedJan 2014
Study CompletionJun 2015
TodayJul 2026
First PostedJan 8, 2014
Enrollment StartJun 1, 2011
Primary CompletionNov 1, 2012
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.5 years ago
Interventions
Aurora Endometrial Ablation Systemdevice
Ablation of the endometrial lining of the uterus using the Aurora System