Trials / Unknown
UnknownNCT01979861
Safety & Effectiveness Study of AEGEA Vapor System to Treat Excessive Uterine Bleeding
A Prospective, Multicenter, Clinical Trial to Evaluate the Safety and Effectiveness of the AEGEA Vapor System for the Treatment of Excessive Uterine Bleeding
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- Sponsor
- Aegea Medical, Inc. · Industry
- Sex
- Female
- Age
- 30 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if the AEGEA Vapor System for endometrial ablation is safe and effective for reducing menstrual blood loss in women with excessive uterine bleeding (menorrhagia)
Detailed description
This is a single-arm, multi-center study with three years of follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | AEGEA Vapor System(TM) | vapor endometrial ablation |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2016-06-01
- Completion
- 2018-06-01
- First posted
- 2013-11-08
- Last updated
- 2016-07-12
Locations
15 sites across 4 countries: United States, Canada, Mexico, Netherlands
Source: ClinicalTrials.gov record NCT01979861. Inclusion in this directory is not an endorsement.