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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 January 2013 |
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Main ID: |
NCT00995878 |
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Date of registration:
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13/10/2009 |
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Primary sponsor: |
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Public title:
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The FIRSTT: Comparing MRgFUS(MR-guided Focused Ultrasound) Versus UAE (Uterine Artery Embolization)for Uterine Fibroids.
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Scientific title:
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The FIRSTT Study: Comparing Focused Ultrasound and Uterine Artery Embolization for Uterine Fibroids |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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180 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00995878 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Lisa G. Peterson, RN |
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Address:
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Telephone:
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507-266-4813 |
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Email:
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mayofibroids@mayo.edu |
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Affiliation:
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Name:
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Elizabeth A. Stewart, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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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
Age minimum:
25 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Fibroids
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Myomas
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Symptomatic Uterine Leiomyomas
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Uterine Fibroids
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Intervention(s)
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Procedure: Focused ultrasound (MRgFUS)
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Procedure: Uterine artery embolization (UAE)
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Primary Outcome(s)
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Symptomatic outcomes measured by validated instruments
[Time Frame: At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment.]
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Secondary Outcome(s)
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Adverse events following treatment
[Time Frame: At baseline, 6 weeks and 6, 12, 24 and 36 months following treatment.]
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Biologic predictors of outcome
[Time Frame: Blood sample is obtained at baseline and at 12, 24, and 36 months following treatment]
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Secondary ID(s)
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09-005095
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1RC1HD063312-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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