MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment. The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.

Official Title
-----------------
MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Clinical Study to Validate the Changes to ExAblate 2000 Device

Conditions
-----------------
Uterine Fibroids, Uterine Leiomyomas

Intervention / Treatment
-----------------
* Device: ExAblate 2000


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility. Able and willing to give consent and able 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 (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone). Fibroids(s) clearly visible on non-contrast MRI. Exclusion Criteria: Metallic implants that are incompatible with MRI Sensitive to MRI contrast agents Severe claustrophobia that would prevent completion of procedure in MR unit Who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus. Pedunculated fibroids Active pelvic inflammatory disease (PID) Active local or systemic infection Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia Intrauterine device (IUD) anywhere in the treatment path Dermoid cyst of the ovary anywhere in the treatment path Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries) Undiagnosed vaginal bleeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ExAblate 2000|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In this IDE for the 4.2 ExAblate system, the goal is evaluation of the new features to confirm that they do not introduce any new safety issues. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibroids, Uterine Leiomyomas, ExAblate, MrgFUS