Trials / Completed
CompletedNCT00215618
Uterine Balloon Treatment for Heavy Period Bleeding.
Clinical Evaluation of Uterine Balloon Therapy System for Menorrhagia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 250 (actual)
- Sponsor
- Ethicon, Inc. · Industry
- Sex
- Female
- Age
- 30 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research is to determine the proportion of women who achieve permanent cessation of bleeding after Uterine Balloon Therapy (UBT) for the treatment of heavy uterine bleeding.
Detailed description
This study was also designed to determine the effect of a post procedure curettage on bleeding patterns and post-operative discharge and pain.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Uterine Balloon Therapy | UBT with post procedure curettage |
| DEVICE | Uterine Balloon Therapy | UBT without post procedure curettage |
Timeline
- Start date
- 2003-03-01
- Primary completion
- 2006-08-01
- Completion
- 2008-09-01
- First posted
- 2005-09-22
- Last updated
- 2009-01-14
Source: ClinicalTrials.gov record NCT00215618. Inclusion in this directory is not an endorsement.