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NCT01142791 · ClinicalTrials.gov registry record · NA
Safety Study of ExAblate for the Treatment of Uterine Fibroids
A NA study, sponsored by InSightec.
- Completed
- Registry status
- NA
- Development phase
- 121
- Enrollment target
NCT01142791 is a NA study that has completed, run by InSightec. The registered enrollment target is 121 participants.
The verdict
NCT01142791, a NA study, has completed, sponsored by InSightec.
- COMPLETED
- Registry status
- NA
- Development phase
- 121 participants
- Enrollment target
Study Summary
The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatment guidelines. Treatment may include up to 100% of individual fibroid volume, within established serosal and sacral treatment margins. The Enhanced sonication is one of the various sonication modes that may lead to increased thermal dose volume of each sonication without additional safety risks. This is an additional treatment tool available in the ExAblate system for the treatment of uterine fibroids. The safety profile of the Enhanced Sonication was investigated under an FDA-regulated IDE study. FDA granted approval of Enhanced Sonication with the requirement to perform a post-approval study to collect additional safety data when treating up to 100% of individual fibroid volume.
Interventions
- DEVICE ExAblate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01142791
The ClinicalTrials.gov registry entry for NCT01142791 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is InSightec, which has 38 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ExAblate is the first listed.
NCT01142791 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01142791 about?
NCT01142791 is a clinical study titled "Safety Study of ExAblate for the Treatment of Uterine Fibroids". The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatment guidelines. Treatment may include up to 100% of individual fibroid volume, within established se...
What is the current status of trial NCT01142791?
This trial is currently completed. It is a NA study. The enrollment target is 121 participants. The study started on 2010-05. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01142791?
The interventions under investigation include: ExAblate (DEVICE).
Who is sponsoring clinical trial NCT01142791?
This trial is sponsored by InSightec, which has 38 total clinical trials registered on ClinicalTrials.gov.
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