Trials / Completed
CompletedNCT02035332
A Two-Phase Clinical Study of the Minerva AURORA Ablation System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Minerva Surgical, Inc. · Industry
- Sex
- Female
- Age
- 35 Years – 50 Years
- Healthy volunteers
- Not accepted
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.
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
- 2011-05-01
- Primary completion
- 2012-11-01
- Completion
- 2015-02-01
- First posted
- 2014-01-14
- Last updated
- 2015-10-23
- Results posted
- 2015-10-23
Locations
3 sites across 1 country: Hungary
Source: ClinicalTrials.gov record NCT02035332. Inclusion in this directory is not an endorsement.