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Trial record 9 of 11 for:    pelvic pain AND NICHD

The FIRSTT: Comparing MRgFUS(MR-guided Focused Ultrasound) Versus UAE (Uterine Artery Embolization)for Uterine Fibroids.

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ClinicalTrials.gov Identifier: NCT00995878
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : January 12, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Elizabeth A. Stewart, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE October 13, 2009
First Posted Date  ICMJE October 15, 2009
Last Update Posted Date January 12, 2018
Actual Study Start Date  ICMJE April 29, 2010
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2011)
Symptomatic outcomes measured by validated instruments [ Time Frame: At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment. ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2009)
Symptomatic outcomes measured by validated instruments [ Time Frame: At baseline 6 weeks and 6 months following treatment. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2013)
  • Adverse events following treatment [ Time Frame: At baseline, 6 weeks and 6, 12, 24 and 36 months following treatment. ]
  • Biologic predictors of outcome [ Time Frame: Blood sample is obtained at baseline and at 12, 24, and 36 months following treatment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2009)
  • Adverse events following treatment [ Time Frame: At baseline, and 6 weeks and 6 months following treatment. ]
  • Biologic predictors of outcome [ Time Frame: Blood is obtained at baseline ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The FIRSTT: Comparing MRgFUS(MR-guided Focused Ultrasound) Versus UAE (Uterine Artery Embolization)for Uterine Fibroids.
Official Title  ICMJE The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids
Brief Summary

The primary goal of this study is to compare the safety and effectiveness of two standard fibroid treatments: MRI guided ultrasound surgery (MRgFUS) and uterine artery embolization (UAE). Both treatments are approved by the Food and Drug Administration (FDA) for women who do not plan to become pregnant.

A second goal of this study is to better understand which symptoms bother women with fibroids the most. Understanding and addressing the symptoms of clinically-significant uterine fibroids is important in order to optimize treatment outcomes and control health care costs.

Women who are eligible to participate in the study, are randomized to one of two treatment arms (UAE or MRgFUS). Women in both arms will receive treatment but will not be able to choose which treatment she will receive.

A comprehensive assessment of symptoms-including experienced pain- will take place at baseline, 6 weeks, and at 6, 12, 24, and 36 months following treatment with UAE and MRgFUS.

Detailed Description

Uterine fibroids affect up to 70 to 80% of women and about 30% of women are symptomatic. Over 200,000 hysterectomies are performed each year for uterine fibroids in the USA. The direct health care costs attributable to uterine fibroids exceed $2.1 billion annually. Fibroids are reported to cause a number of symptoms including heavy or prolonged menstrual bleeding, pelvic pressure, pain with menses and bowel and bladder dysfunction. However, fibroid symptomatology is incompletely understood. Understanding and addressing the myomas pain are important in optimizing treatment outcomes and controlling health care costs from a societal perspective. This study proposes to optimally characterize symptoms and symptom relief in women with leiomyomas severe enough to seek interventional therapy. Secondly we will characterize a variety of symptoms utilizing standardized instruments for other pelvic diseases and symptoms to optimize comparisons with other disease processes.

Clinical and scientific significance of the studies is high. We look to generate resources which can be used at a later time to assess the biologic and genetic variables affecting treatment outcome and to comprehensively assess the societal economic impact of uterine fibroids and their treatment with UAE and MRgFUS.

Participants will be in the study for up to 36 months following fibroid treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Symptomatic Uterine Leiomyomas
  • Fibroids
  • Uterine Fibroids
  • Myomas
Intervention  ICMJE
  • Procedure: Focused ultrasound (MRgFUS)
    MRgFUS treatment will take place in a MRI machine and powerful ultrasound waves go through the abdominal wall to destroy the fibroid or fibroids. No incision is made during this treatment and light sedation is required. There are certain fibroids that may not be treated with this technique and there is no treatment of normal uterine tissue.ough the abdominal wall to destroy the fibroid.
    Other Name: ExAblate 2000
  • Procedure: Uterine artery embolization (UAE)
    UAE treatment takes place on a regular x-ray machine. A small incision is made where the leg meets the trunk and a small tube is used to use very small pellets to block off the blood supply to the entire uterus. Sedation is used. Most fibroids are treated with this technique and normal uterine tissue is also affected.
    Other Names:
    • Uterine Fibroid Embolization
    • UFE
Study Arms  ICMJE
  • Active Comparator: Focused Ultrasound (MRgFUS)
    Intervention: Procedure: Focused ultrasound (MRgFUS)
  • Active Comparator: Uterine Artery Embolization (UAE)
    Intervention: Procedure: Uterine artery embolization (UAE)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2018)
56
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2009)
180
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Women able to give informed consent and willing and able to attend all study visits
  2. Premenopausal women at least 25 years of age
  3. No evidence of High Grade SIL by pap smears or HPV testing within institutional guidelines.

Exclusion Criteria:

  1. Women actively trying for pregnancy or currently pregnant
  2. Uterine size > 20 weeks
  3. Prior myomectomy, UAE, or MRgFUS. Previous hysteroscopic or laparoscopic myomectomy for the removal of only pedunculated leiomyomas (as described in #17, below) will be allowed and evaluated on an individual basis to determine eligibility for treatment.
  4. More than 6 fibroids > than 3 centimeters in maximal diameter
  5. Allergy to either gadolinium or iodinated contrast
  6. Implanted metallic device prohibiting MRI
  7. Severe claustrophobia
  8. BMI which prohibits subject from fitting in MRI device
  9. Severe abdominal scarring precluding safe MRgFUS treatment
  10. Active pelvic infection
  11. Intrauterine contraceptive device in place at the time of treatment
  12. Current use of GnRH agonists or antagonists
  13. Unstable medical conditions requiring additional monitoring during the procedure
  14. Bleeding diathesis requiring medical treatment
  15. Imaging suggestive of malignant disease of uterus, ovary, or cervix
  16. Imaging suggestive of only adenomyosis
  17. Pedunculated submucosal or subserosal myoma with a stalk less than 25% of the maximal fibroid diameter
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00995878
Other Study ID Numbers  ICMJE 09-005095
1RC1HD063312-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elizabeth A. Stewart, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Elizabeth A. Stewart, M.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date January 2018

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