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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01328067
First Posted: April 4, 2011
Last Update Posted: April 27, 2012
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.
Information provided by:
InSightec
  Purpose

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.


Condition Intervention Phase
Uterine Fibroids Bleeding Pelvic Pain Device: Exablate 2100 Procedure: Myomectomy Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for the Treatment of Uterine Fibroids

Resource links provided by NLM:


Further study details as provided by InSightec:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 440
Study Start Date: June 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment
MR guided Focused Ultrasound
Device: Exablate 2100
MRgFUS
Active Comparator: Surgery
Myomectomy
Procedure: Myomectomy
Non-Hysteroscopic Myomectomy

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328067


Locations
United Kingdom
St. Mary's Hospital
London, United Kingdom, W2 1NY
Sponsors and Collaborators
InSightec
Investigators
Principal Investigator: Wady Gedroyc, Prof. St Mary's Hospital, London
  More Information

Additional Information:
Responsible Party: Clinical Project Manager, Insightec
ClinicalTrials.gov Identifier: NCT01328067     History of Changes
Other Study ID Numbers: UF034
First Submitted: March 31, 2011
First Posted: April 4, 2011
Last Update Posted: April 27, 2012
Last Verified: April 2012

Keywords provided by InSightec:
MRgFus
Uterine Fibroids
Pelvic Pain
Quality of Life
Symptomatic Uterine Fibroids

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Pelvic Pain
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Pain
Neurologic Manifestations
Signs and Symptoms