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

NCT00295217 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-12-20

No results posted yet for this 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.

Conditions

  • Uterine Fibroids
  • Uterine Leiomyomas

Interventions

DEVICE

ExAblate 2000

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Principal Investigators

  • George Holland, M.D. · Lahey Clinic

  • Mark Shaman, M.D. · KNI

  • Robert Min, M.D. · Cornell

  • Anne Roberts, M.D. · University of California, San Diego

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-02-28
Completion
2006-10-31

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 NCT00295217 on ClinicalTrials.gov