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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

March 31, 2011
April 26, 2012
June 2011
January 2017   (final data collection date for primary outcome measure)
  • 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).
Same as current
Complete list of historical versions of study NCT01328067 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Uterine Fibroids
  • Bleeding
  • Pelvic Pain
  • Device: Exablate 2100
    MRgFUS
  • Procedure: Myomectomy
    Non-Hysteroscopic Myomectomy
  • Active Comparator: Treatment
    MR guided Focused Ultrasound
    Intervention: Device: Exablate 2100
  • Active Comparator: Surgery
    Myomectomy
    Intervention: Procedure: Myomectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
440
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
Female
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01328067
UF034
No
Clinical Project Manager, Insightec
InSightec
Not Provided
Principal Investigator: Wady Gedroyc, Prof. St Mary's Hospital, London
InSightec
April 2012

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