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MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication

NCT00365989 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-02-05

Study results available
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Summary

This is a phase 3 study to determine the safety of the new features to the FDA approved ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.

Conditions

  • Uterine Leiomyoma
  • Uterine Fibroids

Interventions

DEVICE

ExAblate Enhanced Sonication

Sponsors & Collaborators

  • InSightec

    lead INDUSTRY

Principal Investigators

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

  • Mark Shaman, M.D. · KNI

  • Robert Min, M.D. · Cornell

  • David Gianfelice, M.D. · Toronto General Hospital

  • George Holland, M.D. · Lahey Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United States
  • Canada

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 NCT00365989 on ClinicalTrials.gov