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

Study Overview
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Brief Summary
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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.

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

Conditions
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Uterine Fibroids (Leiomyomas)

Intervention / Treatment
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* Device: Mirabilis High-Intensity Focused Ultrasound Treatment System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Focused ultrasound treatment<br>Patients in this arm will receive fibroid treatment using the Mirabilis High-Intensity Focused Ultrasound Treatment System. | Device: Mirabilis High-Intensity Focused Ultrasound Treatment System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of All Adverse Events Encountered | 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. | Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIFU-related Non-Perfused Volume (NPV) | 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. | The NPV was measured between 0 and 7 days post-treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine Fibroids, Leiomyomas, High-Intensity Focused Ultrasound Ablation, Ultrasonography