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A Phase IV Clinical Study To Evaluate the Safety of MR-Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques

Phase 4
18 Years
Not Enrolling
Uterine Fibroids

Thank you

Trial Information

A Phase IV Clinical Study To Evaluate the Safety of MR-Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques

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 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).

- Patient should be family complete.

- 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.

- Fibroid enhances on MR contrast imaging.

Exclusion Criteria:

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

- Patients who are breast-feeding.

- Patients with active pelvic inflammatory disease (PID).

- Patients with active local or systemic infection.

- Patients experiencing chronic leg or lower back pain within the last 6 months.

- Contraindication for MRI Scan:

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

- Weight greater than 250 lbs (113Kg)

- Implanted ferromagnetic materials and/or devices contraindicated for MR scan

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

- Any other contraindication for MRI Scan

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

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

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

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

- Undiagnosed vaginal bleeding.

- Pedunculated fibroids.

- Uterine size >24 weeks.

Type of Study:


Study Design:

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

Outcome Measure:

Chronic leg pain

Outcome Time Frame:

From treatment to 1-month post-treatment

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2010

Completion Date:

April 2012

Related Keywords:

  • Uterine Fibroids
  • Uterine fibroids
  • MRgFUS
  • ExAblate
  • Focused Ultrasound
  • Symptomatic uterine fibroids
  • Leiomyoma
  • Myofibroma



Duke University Durham, North Carolina  27710
University of California San Francisco San Francisco, California  941104206
UCLA Los Angeles, California  90095
University of Virginia Health System Charlottesville, Virginia  22903
The Methodist Hospital Research Institute Houston, Texas  77030
Borgess Research Institute Kalamazoo, Michigan  49048
UCSD Department of Radiology San Diego, California  92103-8749
University Image Guided Therapy Boca Raton, Florida  33431