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

Mirabilis Medica

Status

Completed

Conditions

Uterine Fibroids (Leiomyomas)

Treatments

Device: Mirabilis High-Intensity Focused Ultrasound Treatment System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01946178

No. 1006

Details and patient eligibility

About

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.

Enrollment

73 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female
Age 18-55 years
Patients seeking relief from uterine fibroid related symptoms, including those scheduled to undergo abdominal hysterectomy due to benign pathology
Patients able and willing to provide informed consent

Exclusion criteria

Visible scar within the HIFU beam path that cannot be avoided
Known or suspected abdominal adhesions between the anterior uterine serosa and the abdominal wall
Currently pregnant or desire to become pregnant in the future
Pelvic malignancy
Pelvic congenital malformation
Acute pelvic infection
Otherwise determined by a physician to be inappropriate for the study