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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01328067
Recruitment Status : Withdrawn
First Posted : April 4, 2011
Last Update Posted : June 15, 2018
Information provided by (Responsible Party):

March 31, 2011
April 4, 2011
June 15, 2018
June 2011
January 2017   (Final data collection date for primary outcome measure)
  • Safety [ Time Frame: 36 months post treatment ]
    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.
  • Efficacy [ Time Frame: 36 months post treatment ]
    Comparison between ExAblate treatment and non-Hysteroscopic Myomectomy in terms of treated patients who did not undergo another interventional treatment for recurrence of uterine fibroid symptoms at up to 36 months (3 years).
Same as current
Complete list of historical versions of study NCT01328067 on Archive Site
Efficacy [ Time Frame: 36 months post treatment ]
  1. Post treatment change in patient's quality of life
  2. Post treatment change in pelvic pain
  3. Post treatment Change in bleeding
  4. Post treatment recovery time
Same as current
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Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids
A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for the Treatment of Uterine Fibroids

The objective of this trial is to evaluate the safety and efficacy of ExAblate for the treatment of uterine fibroids.

Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the study.Women who agree to participate will sign an informed consent and will be randomized to ExAblate treatment or myomectomy.

All patients will be followed through the 36 month visit. Follow-up visits/telephone calls will be completed at 1 week, 2 weeks, 6 weeks, 3 months, 6, 12, 18, 24 and 36 months post treatment.

Patients will be evaluated by assessing their overall physical and mental health as well as for device/procedure related adverse events.

Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Uterine Fibroids
  • Bleeding
  • Pelvic Pain
  • Device: Exablate 2100
  • Procedure: Myomectomy
    Non-Hysteroscopic Myomectomy
  • Active Comparator: Treatment
    MR guided Focused Ultrasound
    Intervention: Device: Exablate 2100
  • Active Comparator: Surgery
    Intervention: Procedure: Myomectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2017
January 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
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Not Provided
Principal Investigator: Wady Gedroyc, Prof. St Mary's Hospital, London
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP