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Brief Title: Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding
Official Title: A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding
Study ID: NCT00496080
Brief 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.
Minimum Age: 25 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Women's Health Research, Phoenix, Arizona, United States
Holy Cross Medical Group, Fort Lauderdale, Florida, United States
University Women's Care - Wayne State University, Southfield, Michigan, United States
Minnesota Gynecology and Surgery, Edina, Minnesota, United States
St. Luke's Hospital, Chesterfield, Missouri, United States
North Carolina Children's & Adults' Clinical Research Foundation, Chapel Hill, North Carolina, United States
Complete Healthcare for Women, Columbus, Ohio, United States
Hahnemann University Hospital - Drexel University School of Med., Philadelphia, Pennsylvania, United States
Matlock Ob/Gyn, Arlington, Texas, United States
St. Joseph's Health Care, London, Ontario, Canada
Hospital Universitario, Monterrey, Nuevo Leon, Mexico
Name: Piet Hinoul, M.D.
Affiliation: Ethicon, Inc.
Role: STUDY_DIRECTOR