Uterine Fibroids (Leiomyomas) Clinical Trial
Official title:
Clinical Study of a Focused Ultrasound Device for Treating Uterine Fibroids and Menorrhagia
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.
n/a
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment