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NCT00628901 · ClinicalTrials.gov registry record · Phase 4
A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)
A Phase 4 study, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT00628901: Completed Phase 4 study, sponsored by Boston Scientific Corporation.
NCT00628901 is a Phase 4 study that has completed, run by Boston Scientific Corporation. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00628901, a Phase 4 study, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate comparability between Contour SE™ Microspheres and Embosphere® Microspheres for achieving post UFE fibroid devascularization in women with symptomatic uterine fibroids.
Primary Outcome
MRI uses a large circular magnet and radio waves to generate signals from atoms in the body. These signals are used to construct images of internal structures. Injection of contrast through an IV is done during the test to enhance the view of the uterus. Contrast enhanced MRI was used as a test in this study to verify if blood supply to the fibroids was blocked or interrupted (devascularization).
Interventions
- PROCEDURE Uterine Fibroid Embolization (UFE)
- DEVICE Contour SE™ Microspheres
- DEVICE Embosphere® Microspheres
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2006-01 |
| Est. Completion | 2011-01 |
| Phase | Phase 4 |
What the finished NCT00628901 record still lists
NCT00628901 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Uterine Fibroid Embolization (UFE) is the first listed.
NCT00628901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00628901 about?
NCT00628901 is a clinical study titled "A Prospective Study Comparing Contour SE™ Microspheres to Embosphere® Microspheres for Treating Symptomatic Uterine Fibroids With Uterine Fibroid Embolization (UFE)". The purpose of this study is to demonstrate comparability between Contour SE™ Microspheres and Embosphere® Microspheres for achieving post UFE fibroid devascularization in women with symptomatic uterine fibroids.
What is the current status of trial NCT00628901?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2006-01. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00628901?
The interventions under investigation include: Uterine Fibroid Embolization (UFE) (PROCEDURE), Contour SE™ Microspheres (DEVICE), Embosphere® Microspheres (DEVICE).
Who is sponsoring clinical trial NCT00628901?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00628901's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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