NCT01946178

Clinical Study of the Mirabilis High-Intensity Focused Ultrasound System for Non-Invasive Treatment of Uterine Fibroids

Clinical Study of a Focused Ultrasound Device for Treating Uterine Fibroids and Menorrhagia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Mirabilis Medica, Inc. · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Fibroids (Leiomyomas)

Interventions

Type	Name	Description
DEVICE	Mirabilis High-Intensity Focused Ultrasound Treatment System	The intervention consists of a treatment session with the device, during which focused ultrasound energy is applied across the intact abdominal wall to ablate appropriately selected uterine fibroids under ultrasound imaging guidance.

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2013-09-19
• Last updated: 2017-05-30
• Results posted: 2016-03-25

Locations

2 sites across 1 country: Mexico