Status:
COMPLETED
The FIRSTT: Comparing MRgFUS(MR-guided Focused Ultrasound) Versus UAE (Uterine Artery Embolization)for Uterine Fibroids.
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Symptomatic Uterine Leiomyomas
Fibroids
Eligibility:
FEMALE
25+ years
Phase:
PHASE4
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 treatme...
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 cos...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 29 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00995878
Start Date
April 29 2010
End Date
December 1 2017
Last Update
January 12 2018
Active Locations (3)
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1
University of California, San Francisco
San Francisco, California, United States, 94116
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Duke University Health System
Durham, North Carolina, United States, 27705