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A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids

18 Years
Not Enrolling
Uterine Fibroids, Bleeding, Pain

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Trial Information

A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids

Inclusion Criteria:

1. Women age 18 or older

2. Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher,
based on patient responses to questions 1-8 of the Uterine Fibroid Symptom and
Health-Related Quality of Life Questionnaire (UFS-QOL).

3. Women who have given written informed consent

4. Women who are able and willing to attend all study visits

5. Patient is pre or peri-menopausal (within 12 months of last menstrual period)

6. Able to communicate sensations during the ExAblate procedure.

7. Uterine fibroids, which are device accessible

8. Fibroid(s) clearly visible on non-contrast MRI.

9. Fibroid(s) enhances on MR contrast imaging

Exclusion Criteria:

1. Women who are pregnant, as confirmed by serum/urine test at time of screening, or
urine pregnancy test on the day of treatment

2. Uterine size > 24 weeks

3. Patients who are breast-feeding

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

5. Patients with active local or systemic infection

6. Contraindication for MRI Scan:

1. Severe claustrophobia that would prevent completion of procedure in the MR unit

2. Weight greater than 250 IBS (113Kg)

3. Implanted ferromagnetic materials and/or devices contraindicated for MR scan

4. Known intolerance to MRI contrast agent (e.g. Gadolinium or Magnevist)

5. Any other contraindication for MRI Scan

7. Extensive abdominal scarring in the beam path

8. Dermoid cyst obstructing the treatment path.

9. Known pelvic malignant or pre-malignant conditions

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

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Description:

Safety of ExAblate 2100 UF V2 will be determined by an evaluation of the incidence and severity of device- and procedure-related adverse events from the first visit through 1-month post-treatment.

Outcome Time Frame:

1 month

Safety Issue:



Israel: Ethics Commission

Study ID:




Start Date:

March 2010

Completion Date:

February 2012

Related Keywords:

  • Uterine Fibroids
  • Bleeding
  • Pain
  • Uterine Fibroids
  • Bleeding
  • Pain
  • Quality of life
  • MR guided focused ultrasound
  • Hemorrhage
  • Leiomyoma
  • Myofibroma