Trials / Terminated
TerminatedNCT00496080
Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding
A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 87 (actual)
- Sponsor
- Ethicon, Inc. · Industry
- Sex
- Female
- Age
- 25 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the safety and effectiveness of Doppler guided uterine artery occlusion (D-UAO) for the reduction of fibroid associated bleeding.
Detailed description
The GYNECARE GYNOCCLUDE D-UAO Instruments are single-use disposable instruments consisting of a GYNECARE GYNOCCLUDE Uterine Stabilizer, a GYNECARE GYNOCCLUDEM Introducer Sheath, a GYNECARE GYNOCCLUDE Doppler Clamp, and a GYNECARE GYNOCCLUDE Coupler.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Doppler-Guided Uterine Artery Occlusion Device (DUAO) | Investigational transvaginal clamp inserted one time for 6 hours. |
Timeline
- Start date
- 2007-06-01
- Primary completion
- 2010-09-01
- Completion
- 2010-10-01
- First posted
- 2007-07-04
- Last updated
- 2012-09-10
- Results posted
- 2012-07-24
Locations
11 sites across 3 countries: United States, Canada, Mexico
Source: ClinicalTrials.gov record NCT00496080. Inclusion in this directory is not an endorsement.