MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids

July 6, 2018 updated by: InSightec

Post Approval Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids

This is a prospective, nonrandomized, multi-center study to evaluate the safety and effectiveness of ExAblate in the treatment of uterine fibroids. All patients will be treated and then followed for 36 months to evaluate the change in their fibroid symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After the PMA Panel, the sponsor was requested to conduct a post-approval study. The objective of this study is to gather additional data to evaluate the safety and long term effectiveness of focused ultrasound treatment, and to include a larger cohort of African-American patients. Patients will be treated following the approved commercial treatment guidelines.

Uterine leiomyoma (fibroids) are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape, and often highly vascular. On T2 weighted MR imaging exams, or T1 exams with contrast, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid. In general, these symptoms can be classified into two categories:

  1. heavy menstrual bleeding, defined as bleeding on heavy days requiring a change of sanitary wear every 2 hours or less, significant clot passage, flooding, substantial prolongation of menstrual periods compared with the patient's prior experience, or anemia.
  2. pelvic pain or pressure, heaviness or discomfort, or similar symptoms in the back, flank or leg attributable to the bulk of the fibroid, urinary frequency, increase in nocturia, difficulty voiding or compression of the ureters with hydronephrosis.

Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement in the initial symptoms that caused her to seek treatment (decrease in pain, bladder or bowel symptoms, or reduction in vaginal bleeding), while experiencing a minimum of co-morbidities from the treatment itself.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Radnet Management
    • Florida
      • Boca Raton, Florida, United States, 33431
        • University MRI
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women'S Hospital
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Virtua
    • Texas
      • Plano, Texas, United States, 75093
        • North Texas Uterine Fibroid Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.
  • Able and willing to give consent and able to attend all study visits.
  • Patient is pre or peri-menopausal (within 12 months of last menstrual period).
  • Able to communicate sensations during the ExAblate procedure.
  • Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).
  • Fibroids(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

  • Metallic implants that are incompatible with MRI
  • Sensitive to MRI contrast agents
  • Severe claustrophobia that would prevent completion of procedure in MR unit
  • Who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.
  • Pedunculated fibroids
  • Active pelvic inflammatory disease (PID)
  • Active local or systemic infection
  • Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia
  • Intrauterine device (IUD) anywhere in the treatment path
  • Dermoid cyst of the ovary anywhere in the treatment path
  • Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries)
  • Undiagnosed vaginal bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Device: ExAblate 2000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement.
Time Frame: Within 1 month of Treatment
Within 1 month of Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InSightec

Investigators

  • Principal Investigator: George Holland, M.D., Lahey Clinic
  • Principal Investigator: Phyllis Gee, M.D., North Texas UFI
  • Principal Investigator: Paul Curtis, M.D., Virtua
  • Principal Investigator: Dennis Sarti, M.D., Radnet Management
  • Principal Investigator: Fred Steinberg, M.D., Univeristy MRI
  • Principal Investigator: Elizabeth Stewart, M.D., Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Actual)

July 9, 2018

Last Update Submitted That Met QC Criteria

July 6, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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