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Eligibility
for females ages 25 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

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.

Official Title

The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids

Details

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.

Keywords

Symptomatic Uterine Leiomyomas Fibroids Uterine Fibroids Myomas Uterine leiomyomas UAE UFE Magnetic resonance guided focused ultrasound MRgFUS Pelvic pain

Eligibility

You can join if…

Open to females ages 25 years and up

  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.

You CAN'T join if...

  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

Locations

  • Mayo Clinic
    Rochester, Minnesota, 55905, USA
  • Duke University Health System
    Durham, North Carolina, 27705, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mayo Clinic
Links
National Institute of Child Health and Human Development
Mayo Clinic Uterine Fibroids Information
Radiology Society of North America Information on UFE
Mayo Clinic Uterine Fibroid Facebook page sharing educational information related to fibroids.
ID
NCT00995878
Phase
Phase 4
Lead Scientist
Vanessa Jacoby
Study Type
Interventional
Last Updated
March 2017