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Magnetic Resonance-Guided Focused Ultrasound to Treat Uterine Fibroids: A Pilot Randomized, Placebo-Controlled Trial


N/A
18 Years
N/A
Open (Enrolling)
Female
Uterine Fibroids

Thank you

Trial Information

Magnetic Resonance-Guided Focused Ultrasound to Treat Uterine Fibroids: A Pilot Randomized, Placebo-Controlled Trial


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Fibroid volume measured on MRI

Outcome Time Frame:

Change from baseline prior to treatment until 3 months after treatment

Safety Issue:

No

Principal Investigator

Vanessa Jacoby, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Institutional Review Board

Study ID:

001

NCT ID:

NCT01377519

Start Date:

June 2011

Completion Date:

December 2012

Related Keywords:

  • Uterine Fibroids
  • Fibroids
  • Uterine
  • Focused Ultrasound
  • Magnetic Resonance focused ultrasound
  • HIFU
  • NOninvasive
  • Treatment
  • Leiomyoma
  • Myofibroma

Name

Location
University of California, San Francisco San Francisco, California  94143