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Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids

NCT01377519 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-11-05

No results posted yet for this study

Summary

This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1 ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants will remain blinded to their group assignment for 3 months. After 3 months, participants will be told their treatment group and those assigned to the sham group will be offered complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate candidates for a 3 month delay in fibroid treatment, such as those with significant anemia. The investigators will assess the change from baseline to 1 and 3 months after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.

Conditions

  • Uterine Fibroids

Interventions

PROCEDURE

MR Guided Focused Ultrasound

This is an FDA approved noninvasive treatment for fibroids that uses highly focused ultrasound waves to damage fibroid tissue.

PROCEDURE

Placebo MR Guided Focused Ultrasound

This is a placebo treatment that requires a participant to undergo identical procedures as those of the actual MR Guided Focused Ultrasound procedure, but higly focused ultrasound waves are not directed at the uterine fibroid.

Sponsors & Collaborators

Principal Investigators

  • Vanessa Jacoby, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01377519 on ClinicalTrials.gov