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Brief Title: Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
Official Title: Clinical Study to Assess the Safety and Effectiveness of VizAblate(tm) Intrauterine Ultrasound-guided RF Ablation (IUUSgRFA) of Submucosal and Intramural Uterine Fibroids on the Reduction of Pictorial Blood Loss Assessment Scores
Study ID: NCT00768742
Brief Summary: The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.
Detailed Description:
Minimum Age: 25 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Victoria General Hospital; Mature Women's Centre, Winnipeg, Manitoba, Canada
Shirley E. Greenberg Women's Health Centre, The Ottawa Hospital, Ottawa, Ontario, Canada
St. Joseph's Health Centre, Toronto, Ontario, Canada
Name: David Toub, M.D.
Affiliation: Gynesonics
Role: STUDY_DIRECTOR