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NCT00995878 · ClinicalTrials.gov registry record · Phase 4
The FIRSTT: Comparing MRgFUS(MR-guided Focused Ultrasound) Versus UAE (Uterine Artery Embolization)for Uterine Fibroids.
A Phase 4 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 56
- Enrollment target
NCT00995878: Completed Phase 4 study, sponsored by Mayo Clinic.
NCT00995878 is a Phase 4 study that has completed, run by Mayo Clinic. The registered enrollment target is 56 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00995878, a Phase 4 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 56 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Focused ultrasound (MRgFUS)
- PROCEDURE Uterine artery embolization (UAE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2010-04-29 |
| Est. Completion | 2017-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00995878
The ClinicalTrials.gov registry entry for NCT00995878 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Focused ultrasound (MRgFUS) is the first listed.
NCT00995878 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00995878 about?
NCT00995878 is a clinical study titled "The FIRSTT: Comparing MRgFUS(MR-guided Focused Ultrasound) Versus UAE (Uterine Artery Embolization)for Uterine Fibroids.". 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 pregn...
What is the current status of trial NCT00995878?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2010-04-29. Estimated completion is 2017-12.
What interventions are being tested in trial NCT00995878?
The interventions under investigation include: Focused ultrasound (MRgFUS) (PROCEDURE), Uterine artery embolization (UAE) (PROCEDURE).
Who is sponsoring clinical trial NCT00995878?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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