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NCT01285960 · ClinicalTrials.gov registry record · NA
ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids
A NA study, sponsored by InSightec.
- Completed
- Registry status
- NA
- Development phase
- 108
- Enrollment target
NCT01285960: Completed NA study, sponsored by InSightec.
NCT01285960 is a NA study that has completed, run by InSightec. The registered enrollment target is 108 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01285960, a NA study, has completed, sponsored by InSightec.
- COMPLETED
- Registry status
- NA
- Development phase
- 108 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids. The ExAblate System is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. In this particular study, the targeted tissue is uterine fibroids. Each sonication is used to heat small spots in the fibroid much like a magnifying glass can be used to focus light to heat a spot. The heat created kills a portion of the fibroid with the goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are performed until the entire fibroid is treated or the treated volume is determined to be appropriate. The ExAblate system is commercially approved in the United States to treat symptomatic uterine fibroids. The ExAblate UF V2 System is an experimental device and is being investigated in this study. While similar to the commercial system, the ExAblate UF V2 device includes the following major changes, among others, which are intended to improve device performance and safety: * Up and down movement of the ultrasound transducer, in an attempt to improve fibroid treatment by moving the ultrasound focal point within the targeted fibroid. * Ultrasound energy can be turned off for a specific area in an attempt to minimize amount of energy passing through sensitive areas of the body.
Primary Outcome
The hypothesis for this study was that the percentage of subjects experiencing persistent leg pain would be less than 10%
Interventions
- DEVICE ExAblate Treatment UF V2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2012-05 |
| Est. Completion | 2016-04 |
| Phase | NA |
What the finished NCT01285960 record still lists
NCT01285960 is an interventional study that assigns participants to a tested intervention. The registered 108 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 (92% lower).
The record links to 0 conditions, and to 1 intervention - of which ExAblate Treatment UF V2 is the first listed.
NCT01285960 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01285960 about?
NCT01285960 is a clinical study titled "ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids". The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids. The ExAblate System is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound en...
What is the current status of trial NCT01285960?
This trial is currently completed. It is a NA study. The enrollment target is 108 participants. The study started on 2012-05. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01285960?
The interventions under investigation include: ExAblate Treatment UF V2 (DEVICE).
Who is sponsoring clinical trial NCT01285960?
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 NCT01285960's enrollment target sits among peer trials
108 825th of 2000 higher than 1,171 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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