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Sonalleve Fibroid Ablation Pivotal Clinical Trial for MR-HIFU of Uterine Fibroids

NCT01504308 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2017-04-05

No results posted yet for this study

Summary

The purpose of this clinical study is to determine whether treatment with the Philips Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU) system is effective in the treatment symptomatic uterine leiomyomas (uterine fibroids).

Conditions

  • Uterine Fibroids

Interventions

DEVICE

MR-HIFU treatment

A treatment session with the Philips Sonalleve MR-HIFU device for thermal ablation of uterine fibroids with high-intensity focused ultrasound.

DEVICE

Sham treatment

A pretend treatment session with the Philips Sonalleve MR-HIFU system in which no therapeutic ultrasound doses are delivered.

Sponsors & Collaborators

  • Philips Healthcare

    lead INDUSTRY

Principal Investigators

  • John H Fischer II, MD · St. Luke's Episcopal Hospital, Houston, Texas, United States

  • Robert K Zurawin, MD · St. Luke's Episcopal Hospital, Houston, Texas, United States

  • Elizabeth David, MD · Sunnybrook Health Sciences Center, Toronto, Ontario, Canada

  • Hyo Keun Lim, MD · Samsung Medical Center, Seoul, Republic of Korea

  • Aytekin Oto, MD · University of Chicago, Chicago, Illinois, United States

  • Amanda Yunker, D.O. · Vanderbilt Medical Center

  • Peter Liu, M.D. · University of Michigan

  • Rajiv Chopra, PhD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2016-03-31
Completion
2016-03-31
FDA Device
Yes

Countries

  • United States
  • Canada
  • South Korea

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 NCT01504308 on ClinicalTrials.gov