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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

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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