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

Completed · Phase 4

Conditions studied: Symptomatic Uterine Leiomyomas, Fibroids, Uterine Fibroids, Myomas

In brief

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.

Key facts

Study ID

NCT00995878

Run by

Mayo Clinic

People needed

56

Starts

2010-04-29

Expected to finish

2017-12-01

Last updated by the study team

2018-01-12

Who can join

Age: 25 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Women actively trying for pregnancy or currently pregnant
• Uterine size > 20 weeks
• 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.
• More than 6 fibroids > than 3 centimeters in maximal diameter
• Allergy to either gadolinium or iodinated contrast
• Implanted metallic device prohibiting MRI
• Severe claustrophobia
• BMI which prohibits subject from fitting in MRI device
• Severe abdominal scarring precluding safe MRgFUS treatment
• Active pelvic infection
• Intrauterine contraceptive device in place at the time of treatment
• Current use of GnRH agonists or antagonists
• Unstable medical conditions requiring additional monitoring during the procedure
• Bleeding diathesis requiring medical treatment
• Imaging suggestive of malignant disease of uterus, ovary, or cervix
• Imaging suggestive of only adenomyosis
• Pedunculated submucosal or subserosal myoma with a stalk less than 25% of the maximal fibroid diameter

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Duke University Health System — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.