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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:
Information provided by:
InSightec
ClinicalTrials.gov Identifier:
NCT01328067
First received: March 31, 2011
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by InSightec:

Primary Outcome Measures:
  • Safety [ Time Frame: 36 months post treatment ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Sponsor's website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Clinical Project Manager, Insightec
ClinicalTrials.gov Identifier: NCT01328067     History of Changes
Other Study ID Numbers: UF034
Study First Received: March 31, 2011
Last Updated: April 26, 2012
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 22, 2013