Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids (PROMISe)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01377519
First received: June 15, 2011
Last updated: January 15, 2014
Last verified: January 2014

June 15, 2011
January 15, 2014
June 2011
September 2012   (final data collection date for primary outcome measure)
  • Fibroid volume measured on MRI [ Time Frame: Change from baseline prior to treatment until 3 months after treatment ] [ Designated as safety issue: No ]
  • Fibroid symptoms reported by participant [ Time Frame: Change from baseline prior to treatment to 1 and 3 months after treatment ] [ Designated as safety issue: No ]
  • Red blood cell count (hematocrit) [ Time Frame: Change from baseline prior to treatment and 3 months after treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01377519 on ClinicalTrials.gov Archive Site
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Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids
Magnetic Resonance-Guided Focused Ultrasound to Treat Uterine Fibroids: A Pilot Randomized, Placebo-Controlled Trial

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Uterine Fibroids
  • 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.
  • Active Comparator: MR Guided Focused Ultrasound
    Intervention: Procedure: MR Guided Focused Ultrasound
  • Placebo Comparator: Placebo MR Guided Focused Ultrasound
    Intervention: Procedure: Placebo MR Guided Focused Ultrasound
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age>18 years
  • Premenopausal
  • Symptomatic fibroids
  • Fibroids accessible for focused ultrasound treatment

Exclusion criteria:

  • Desires future fertility
  • Current pregnancy
  • Hematocrit <30%
  • Emergency room visit in last 3 months for fibroid symptoms
  • History of venous thromboembolism
  • Fibroids that are: >10cm, non-enhancing with contrast
  • Adenomyosis
  • Contraindications to undergoing MRI
  • Unexplained menstrual irregularity
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01377519
001
Yes
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Vanessa Jacoby, MD University of California, San Francisco
University of California, San Francisco
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP