ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids

A Clinical Study to Evaluate Safety of the ExAblate Model 2100 Type 1.1 System (ExAblate 2100/2000 UF V2 System) in the Treatment of Symptomatic Uterine Fibroids

The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids.

The ExAblate System is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. In this particular study, the targeted tissue is uterine fibroids. Each sonication is used to heat small spots in the fibroid much like a magnifying glass can be used to focus light to heat a spot. The heat created kills a portion of the fibroid with the goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are performed until the entire fibroid is treated or the treated volume is determined to be appropriate.

The ExAblate system is commercially approved in the United States to treat symptomatic uterine fibroids.

The ExAblate UF V2 System is an experimental device and is being investigated in this study. While similar to the commercial system, the ExAblate UF V2 device includes the following major changes, among others, which are intended to improve device performance and safety:

• Up and down movement of the ultrasound transducer, in an attempt to improve fibroid treatment by moving the ultrasound focal point within the targeted fibroid.
• Ultrasound energy can be turned off for a specific area in an attempt to minimize amount of energy passing through sensitive areas of the body.

Inclusion Criteria:

1. Patient age 18 or older
2. Patients who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.
3. Patients who have given written informed consent
4. Patients who are able and willing to attend all study visits
5. Patients who are pre or peri-menopausal (within 12 months of last menstrual period)
6. Patients should have completed child bearing
7. Able to communicate sensations during the ExAblate procedure.
8. 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).
9. Fibroid(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

1. Pregnant patients, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.

2. Uterine size >24 weeks.

3. Patients with pedunculated fibroids

4. Patients with active pelvic inflammatory disease (PID).

5. Patients with active local or systemic infection

6. Patients experiencing any symptoms of lower extremity neuropathy, including chronic leg or lower back pain, within the last 6 months

7. Contraindication for MRI Scan:

   • Severe claustrophobia that would prevent completion of procedure in the MR unit
   • Metallic implants that are incompatible with MRI
   • Sensitivity to MRI contrast agents
   • Any other contraindication for MRI Scan

8. Extensive abdominal scarring in the beam path (that cannot be avoided by redirection of the beam)

9. Dermoid cyst of the ovary anywhere in the treatment path.

10. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.

11. Intrauterine device (IUD) anywhere in the treatment path

12. Undiagnosed vaginal bleeding