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Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids

NCT00131365 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-06-12

Study results available
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Summary

The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment.

Indications for use for this system is: '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

  • Leiomyoma

Interventions

DEVICE

ExAblate 2000

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Principal Investigators

  • Robert Min, M.D. · Cornell Vascular

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2009-01-31
Completion
2009-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00131365 on ClinicalTrials.gov