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A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for the Treatment of Uterine Fibroids

Phase 4
18 Years
50 Years
Not Enrolling
Uterine Fibroids, Bleeding, Pelvic Pain

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Trial Information

A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for the Treatment of 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 (raw score) 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 currently pregnant

2. Uterine size > 24 cm W/O the cervix

3. More than 4 clinically significant fibroids (per MRI)

4. Prior myomectomy, UAE

5. Allergy to either gadolinium or iodinated contrast

6. Implanted metallic device prohibiting MRI

7. Severe claustrophobia

8. Active pelvic infection

9. Current use of intrauterine contraceptive device

10. Unstable medical conditions requiring additional monitoring during the procedure

11. Bleeding diathesis requiring medical treatment

12. Imaging suggestive of malignant disease of uterus, ovary, or cervix

13. Imaging and suggestive of adenomyosis.

14. Pedunculated submucosal or pedunculated subserosal myoma

15. Size and weight which prohibits subject from fitting in MRI device

16. Unavoidable, scarring, skin folds or irregularity, bowel, pubic bone, IUD, surgical
clips or hard implants in the beam path.

17. Hyper intense fibroid relatively to the uterus muscle

18. Women with ovarian dermoid cyst anywhere in the treatment path

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Safety will be evaluated by recording and assessing the incidence and severity of major adverse events from treatment through the 3 years follow-up period.

Outcome Time Frame:

36 months post treatment

Safety Issue:


Principal Investigator

Wady Gedroyc, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Mary's Hospital


United Kingdom: Research Ethics Committee

Study ID:




Start Date:

June 2011

Completion Date:

June 2017

Related Keywords:

  • Uterine Fibroids
  • Bleeding
  • Pelvic Pain
  • MRgFus
  • Uterine Fibroids
  • Pelvic Pain
  • Quality of Life
  • Symptomatic Uterine Fibroids
  • Hemorrhage
  • Leiomyoma
  • Myofibroma
  • Pelvic Pain