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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: Completed NA study, sponsored by InSightec.
NCT01142791 is a NA study that has completed, run by InSightec. The registered enrollment target is 121 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The hypothesis was that over 90% of subjects would not experience chronic leg pain. A lower 95% Confidence Limit \> 0.90 was considered statistically successful.
Interventions
- DEVICE ExAblate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-04 |
| Phase | NA |
What the finished NCT01142791 record still lists
NCT01142791 is an interventional study that assigns participants to a tested intervention. The registered 121 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which ExAblate is the first listed.
NCT01142791 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01142791's enrollment target sits among peer trials
121 762nd of 2000 higher than 1,239 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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