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NCT00295217 · ClinicalTrials.gov registry record · Phase 3

MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation

A Phase 3 study, sponsored by InSightec.

Completed
Registry status
Phase 3
Development phase
15
Enrollment target

NCT00295217: Completed Phase 3 study, sponsored by InSightec.

NCT00295217 is a Phase 3 study that has completed, run by InSightec. The registered enrollment target is 15 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00295217, a Phase 3 study, has completed, sponsored by InSightec.

COMPLETED
Registry status
Phase 3
Development phase
15 participants
Enrollment target

Study Summary

The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment. The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.

Interventions

  • DEVICE ExAblate 2000

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2006-02
Est. Completion 2006-10
Phase Phase 3
InSightec

38 total trials

What the finished NCT00295217 record still lists

NCT00295217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which ExAblate 2000 is the first listed.

NCT00295217 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00295217 about?

NCT00295217 is a clinical study titled "MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation". The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment. The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sp...

What is the current status of trial NCT00295217?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2006-02. Estimated completion is 2006-10.

What interventions are being tested in trial NCT00295217?

The interventions under investigation include: ExAblate 2000 (DEVICE).

Who is sponsoring clinical trial NCT00295217?

This trial is sponsored by InSightec, which has 38 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00295217's enrollment target sits among peer trials

15 1977th of 2000 higher than 18 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00295217, the US trial registry maintained by the National Library of Medicine. NCT00295217 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.