Clinical Trials Directory

Trials / Completed

CompletedNCT00295217

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

MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Clinical Study to Validate the Changes to ExAblate 2000 Device

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
15 (planned)
Sponsor
InSightec · Industry
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEExAblate 2000

Timeline

Start date
2006-02-01
Completion
2006-10-01
First posted
2006-02-23
Last updated
2018-12-20

Locations

4 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00295217. Inclusion in this directory is not an endorsement.