A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
No Surgical Re-intervention
Number of participants without any subsequent surgical procedure intended to manage fibroid symptoms performed. Potential procedures included surgical hysterectomy or dilatation and curettage (D&C) for treatment of menorrhagia; uterine artery embolization (UAE) or laparoscopic uterine artery occlusion; endometrial resection or ablation; myomectomy or myolysis.
Piet Hinoul, M.D.
United States: Food and Drug Administration
|St. Luke's Hospital||Kansas City, Missouri 64111|
|Women's Health Research||Phoenix, Arizona 85015|
|Holy Cross Medical Group||Fort Lauderdale, Florida 33308|
|University Women's Care - Wayne State University||Southfield, Michigan 48034|
|Minnesota Gynecology and Surgery||Edina, Minnesota 55435|
|North Carolina Children's & Adults' Clinical Research Foundation||Chapel Hill, North Carolina 27514|
|Complete Healthcare for Women||Columbus, Ohio 43231|
|Hahnemann University Hospital - Drexel University School of Med.||Philadelphia, Pennsylvania 19102|
|Matlock Ob/Gyn||Arlington, Texas 76014|