Spots Global Cancer Trial Database for Clinical Study of the Mirabilis High-Intensity Focused Ultrasound System for Non-Invasive Treatment of Uterine Fibroids
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Trial Identification
Brief Title: Clinical Study of the Mirabilis High-Intensity Focused Ultrasound System for Non-Invasive Treatment of Uterine Fibroids
Official Title: Clinical Study of a Focused Ultrasound Device for Treating Uterine Fibroids and Menorrhagia
Study ID: NCT01946178
Conditions
Study Description
Brief Summary: The Mirabilis High-Intensity Focused Ultrasound (HIFU) Treatment System delivers therapeutic focused ultrasound energy to the uterus under integrated ultrasound imaging guidance to offer non-invasive treatment for uterine fibroids. The purpose of this clinical study is to assess the initial safety and performance of the Mirabilis HIFU Treatment System for transabdominal treatment of uterine fibroids in eligible women who are scheduled to undergo hysterectomy following treatment with the device or who are seeking relief from fibroid-related symptoms.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Hospital Torre Medica, Ciudad de Mexico, Distrito Federal, Mexico
Hospital Universitario, Universidad Autonoma de Nuevo Leon, Monterrey, Nuevo Leon, Mexico
Contact Details
Name: Michael Lau, M.D.
Affiliation: Mirabilis Medica, Inc.
Role: STUDY_DIRECTOR
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