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

Not Applicable

Completed

• Conditions: Uterine Fibroids (Leiomyomas)
• Interventions: Device: Mirabilis High-Intensity Focused Ultrasound Treatment System

• Registration Number: NCT01946178
• Lead Sponsor: Mirabilis Medica, Inc.

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

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2013-09-16
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2016-02-24
• Results First Submitted QC: 2016-02-24
• Results First Posted: 2016-03-25
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Focused ultrasound treatment	Mirabilis High-Intensity Focused Ultrasound Treatment System	Patients in this arm will receive fibroid treatment using the Mirabilis High-Intensity Focused Ultrasound Treatment System.

Primary Outcome Measures

Name	Time	Method
Evaluation of All Adverse Events Encountered	Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment).	Safety of the treatment was determined by evaluating the incidence of Adverse Events and Adverse Device Effects. Adverse Device Effects are Adverse Events that are related to treatment with the device. Relatedness of an Adverse Event to the treatment was determined on a case-by-case basis by the investigator. The average number of Serious Adverse Device Effects per patient and the average number of Non-Serious Adverse Device Effects per patient are reported to provide numeric outcomes of this evaluation.

Secondary Outcome Measures

Name	Time	Method
HIFU-related Non-Perfused Volume (NPV)	The NPV was measured between 0 and 7 days post-treatment.	Efficacy of the treatment was quantified by measuring the HIFU-related Non-Perfused Volume (NPV) of tissue in each patient using either post-treatment contrast-enhanced magnetic resonance imaging (MRI) or pathology assessment following hysterectomy. The NPV is used to measure the amount of tissue that was treated during the procedure.

Trial Locations

Locations (2)

Hospital Torre Medica; 🇲🇽 Ciudad de Mexico, Distrito Federal, Mexico

Hospital Universitario, Universidad Autonoma de Nuevo Leon; 🇲🇽 Monterrey, Nuevo Leon, Mexico