Trials / Completed
CompletedNCT02029911
A Multi-Center, Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 63 (actual)
- Sponsor
- Minerva Surgical, Inc. · Industry
- Sex
- Female
- Age
- 25 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Aurora Endometrial Ablation System | Ablation of the endometrial lining of the uterus using the Aurora System |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2012-11-01
- Completion
- 2015-06-01
- First posted
- 2014-01-08
- Last updated
- 2015-11-05
- Results posted
- 2015-11-05
Locations
3 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT02029911. Inclusion in this directory is not an endorsement.