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

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.

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Key information

Conditions

Uterine Fibroids (Leiomyomas) Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Torre Medica, Mexico City, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirabilis High-Intensity Focused Ultrasound Treatment System

Device

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.

Primary outcomes

Evaluation of All Adverse Events Encountered

Time frame: 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 outcomes

HIFU-related Non-Perfused Volume (NPV)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mirabilis Medica, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2015
First posted: Sep 19, 2013
Registry last updated: May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed