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Brief Title: Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids Compared to Myomectomy
Official Title: Multicenter, Randomized Phase III Study of MR-Guided Focused Ultrasound Surgery for the Treatment of Uterine Fibroids (MRgFUS TUF) Compared to Myomectomy in Symptomatic Medication and Not Sufficiently Treatable Uterine Fibroids
Study ID: NCT03948789
Brief Summary: The aim of the study is to answer the question, whether in patients with symptomatic and medically not sufficiently treatable uterine fibroids (population) the "Magnetic-Resonance-Guided Focused Ultrasound Surgery" short, MRgFUS-TUF (intervention) offers less burdensome therapy and patient-relevant advantages (symptom relief) compared to the operative myomectomy (comparison). The study will hence investigate the therapeutic benefit of this method.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Krankenhaus Nordwest, Frankfurt, Hessen, Germany
FOKUS Radiologische Gemeinschaftspraxis, Göttingen, , Germany
Leipzig University, Leipzig, , Germany
Marienhospital, Stuttgart, , Germany
Name: Thorsten O Götze, PD Dr. med.
Affiliation: Krankenhaus Nordwest
Role: PRINCIPAL_INVESTIGATOR