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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

18 Years
64 Years
Open (Enrolling)
Uterine Fibroid(s)

Thank you

Trial Information

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

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. Demoid 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Leg pain or lower extremity neuropathy persisting or occuring greater than 10 days following treatment

Outcome Time Frame:

From treatment to 1-month post-treatment

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2012

Completion Date:

December 2013

Related Keywords:

  • Uterine Fibroid(s)
  • Uterine fibroids
  • MRgFUS
  • ExAblate
  • Focused Ultrasound
  • Symptomatic uterine fibroids
  • Leiomyoma
  • Myofibroma



Stanford University Medical CenterStanford, California  94305-5408
Brigham and Women's HospitalBoston, Massachusetts  02115
University of Virginia Health SystemCharlottesville, Virginia  22903