Trials / Completed
CompletedNCT02842736
A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 242 (actual)
- Sponsor
- Channel Medsystems · Industry
- Sex
- Female
- Age
- 25 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the safety and effectiveness of the Cerene Cryotherapy Device in reducing menstrual bleeding in women with heavy menstrual bleeding (menorrhagia) due to benign causes for whom child bearing is complete.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cerene(R) Cryotherapy Device |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2018-04-01
- Completion
- 2020-05-01
- First posted
- 2016-07-25
- Last updated
- 2021-01-05
- Results posted
- 2019-06-06
Locations
12 sites across 3 countries: United States, Canada, Mexico
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02842736. Inclusion in this directory is not an endorsement.