Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids

Study Overview
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Brief Summary
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The objective of this trial is to evaluate the safety and efficacy of ExAblate for the treatment of uterine fibroids. Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the study.Women who agree to participate will sign an informed consent and will be randomized to ExAblate treatment or myomectomy. All patients will be followed through the 36 month visit. Follow-up visits/telephone calls will be completed at 1 week, 2 weeks, 6 weeks, 3 months, 6, 12, 18, 24 and 36 months post treatment. Patients will be evaluated by assessing their overall physical and mental health as well as for device/procedure related adverse events.

Official Title
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A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for the Treatment of Uterine Fibroids

Conditions
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Uterine Fibroids, Bleeding, Pelvic Pain

Intervention / Treatment
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* Device: Exablate 2100
* Procedure: Myomectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women age 18 or older Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher, based on patient responses to questions 1-8 (raw score) of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL). Women who have given written informed consent Women who are able and willing to attend all study visits Patient is pre or peri-menopausal (within 12 months of last menstrual period) Able to communicate sensations during the ExAblate procedure Uterine fibroids, which are device accessible Fibroid(s) clearly visible on non-contrast MRI. Fibroid(s) enhances on MR contrast imaging Exclusion Criteria: Women currently pregnant Uterine size > 24 cm W/O the cervix More than 4 clinically significant fibroids (per MRI) Prior myomectomy, UAE Allergy to either gadolinium or iodinated contrast Implanted metallic device prohibiting MRI Severe claustrophobia Active pelvic infection Current use of intrauterine contraceptive device Unstable medical conditions requiring additional monitoring during the procedure Bleeding diathesis requiring medical treatment Imaging suggestive of malignant disease of uterus, ovary, or cervix Imaging and suggestive of adenomyosis. Pedunculated submucosal or pedunculated subserosal myoma Size and weight which prohibits subject from fitting in MRI device Unavoidable, scarring, skin folds or irregularity, bowel, pubic bone, IUD, surgical clips or hard implants in the beam path. Hyper intense fibroid relatively to the uterus muscle Women with ovarian dermoid cyst anywhere in the treatment path

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>MR guided Focused Ultrasound | Device: Exablate 2100<br>* MRgFUS<br>|
| Active Comparator: Surgery<br>Myomectomy | Procedure: Myomectomy<br>* Non-Hysteroscopic Myomectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Safety will be evaluated by recording and assessing the incidence and severity of major adverse events from treatment through the 3 years follow-up period. | 36 months post treatment | 
| Efficacy | Comparison between ExAblate treatment and non-Hysteroscopic Myomectomy in terms of treated patients who did not undergo another interventional treatment for recurrence of uterine fibroid symptoms at up to 36 months (3 years). | 36 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Post treatment change in patient's quality of life Post treatment change in pelvic pain Post treatment Change in bleeding Post treatment recovery time | 36 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRgFus, Uterine Fibroids, Pelvic Pain, Quality of Life, Symptomatic Uterine Fibroids