Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas

Study Overview
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Brief Summary
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Single arm, first-in human feasibility study using the Symphony - MRI guided focused ultrasound system for the treatment of leiomyomas. The study is expected to accrue over 12 months. This study will help determine the feasibility to ablate leiomyomas, as measured by MR thermometry and contrast enhanced imaging. In addition, the study will look at the efficacy and safety of the treatment, as measured by the reduction in fibroid size and reduction in symptom severity score and adverse events. This study will help develop future pivotal trials using the same device.

Official Title
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MRI-guided High Intensity Focused Ultrasound Ablation of Leiomyomas. Single Arm, Feasibility Study Using the Symphony - MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas

Conditions
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Fibroid, Leiomyoma

Intervention / Treatment
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* Device: Symphony MRI guided High Intensity Focused Ultrasound (HIFU)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MR-HFU device accessibility to fibroids that at least 50% of fibroid volume can be treated Fibroids selected for treatment meet the following criteria Total planned ablation volume of all fibroids should not exceed 500 ml AND Completely non-enhancing fibroids should not be treated Transformed SSS score >= 40 Pre- or peri-menopausal, as indicated by clinical evaluation Weight < 140 kg or 310 lbs Willing and able to attend all study visits Willing and able to use reliable contraception methods Uterine size < 24 weeks Cervical cell assessment by PAP: normal, LOW Grade SIL, Low risk HPV or ASCUS subtypes of cervical tissue Waist circumference <110cm or 43 inches Exclusion Criteria: Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis, prolonged bleeding requiring further evaluation as determined by patient's gynecologist) Positive pregnancy test Extensive scarring along anterior lower - abdominal wall (>50% of area) Surgical clips in the potential path of the HIFU beam Tattoos in the potential path of the HIFU beam MRI contraindicated MRI contrast agent contraindicated (including renal insufficiency) Calcification around or throughout uterine tissue that may affect treatment Communication barrier Fibroids not quantifiable on MRI (e.g., multi-fibroid cases where volume measurements are not feasible) Pedunculated fibroids Bowel loops int he ultrasound beam path Patients with inability to tolerate prolonged prone position for up to 3 hours Patient with unstable medical conditions Patients with coagulopathy or under current anti-coagulation therapy

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: Pilot single arm feasibility trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MR Guided High Intensity Focused Ultrasound<br> | Device: Symphony MRI guided High Intensity Focused Ultrasound (HIFU)<br>* The use of the MRI-HIFU for the ablation of leiomyomas<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ability to ablate fibroid tissue measured by temperature elevation | Measured by MRI thermometry | 1 year | 
| The ability to ablate fibroid tissue indicated by Non-Perfused Volume (NPV) | Measure by contrast enhanced imaging | 1 year | 
| Safety of the system measured by collection of adverse events related to potential damage to tissue outside the treatment zone | Safety will be measured by collection of adverse events related to potential damage to tissue outside the treatment zone. | 1 year | 
| Safety of the system based on damage to skin measured by collection of adverse events related to potential damage to skin over the treatment volume | Safety will be measured by collection of adverse events related to potential damage to skin over the treatment volume. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment efficacy to reduce fibroid size | Reduction of fibroid volume in milliliters | 1 year | 
| Treatment efficacy to reduce fibroid size by NPV | Measured by non-perfused volume in milliliters | 1 year | 
| Treatment efficacy to reduce symptom severity by Symptom Severity Scores (SSS) | Change in symptoms to be quantified by Symptom Severity Scores (SSS) derived from Uterine Fibroid Symptom and Quality of Life questionnaire. | 1 year |