MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication

A Clinical Study To Evaluate the Safety and Efficacy of MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques

This is a phase 3 study to determine the safety of the new features to the FDA approved ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.

Study Overview

• Status: Completed
• Conditions: Uterine Fibroids; Uterine Leiomyoma
• Intervention / Treatment: Device: ExAblate Enhanced Sonication

Detailed Description

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. InSightec has developed an Enhanced Sonication (ES) technique for the ablation of these fibroids. This mode of tissue ablation has been added to the already FDA approved ExAblate system. The goal of this ES technique is to provide an additional treatment tool that will enhance the treatment effect without additional risks while preserving ALL clinical features of the current commercially approved version.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, MG5 2C4
      • Toronto General Hospital
• United States
  • California
    • La Jolla, California, United States, 92037
      • University of California at San Diego
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic
  • Michigan
    • Kalamazoo, Michigan, United States, 49048
      • KNI
  • New York
    • New York, New York, United States, 10022
      • Cornell Vascular

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Women age 18 or older, who present with symptomatic fibroids
2. Women who have given written informed consent
3. Women who are able and willing to attend all study visits.
4. Patient is pre or peri-menopausal (within 12 months of last menstrual period).
5. Able to communicate sensations during the ExAblate procedure.
6. 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).
7. Fibroids(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

1. Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment
2. Patient who desire to become pregnant in the future.
3. Patients who are breast-feeding.
4. Patients with an active pelvic inflammatory disease (PID)
5. Active local or systemic infection
6. Metallic implants that are incompatible with MRI
7. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)
8. Severe claustrophobia that would prevent completion of procedure in the MR unit.
9. Extensive abdominal scarring in the beam pass or dermoid cyst of the ovary anywhere in the treatment path.
10. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
11. Pedunculated fibroids.
12. Intrauterine device (IUD) anywhere in the treatment path
13. Undiagnosed vaginal bleeding.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ExAblate Enhanced Sonication Test Arm; The intervention to be administered is ExAblate Enhanced Sonication. The purpose of this study is to examine the safety profile of the ExAblate Enhanced Sonication mode to insure that no new safety issues are introduced compared to the normal focused ultrasound mode.	Device: ExAblate Enhanced Sonication; Other Names: Magnetic Resonance guided Focused Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events	The study objective is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.	Within 1 month of treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Enhanced Sonication Normalized Thermal Dose Volume	The secondary end point of the study is to evaluate the mean normalized Enhanced Sonication thermal dose volume. Normalized dose volume is a function of the sonication dose volume divided by the energy transmitted measured from the the MR thermometry imaging.	During treatment
Number of Participants With Adverse Events		Within 1 month of treatment

Collaborators and Investigators

• Sponsor: InSightec
• Investigators: Principal Investigator: George Holland, M.D., Lahey Clinic; Principal Investigator: Mark Shaman, M.D., KNI; Principal Investigator: Robert Min, M.D., Cornell; Principal Investigator: Anne Roberts, M.D., University of California, San Diego; Principal Investigator: David Gianfelice, M.D., Toronto General Hospital

Publications and helpful links

Helpful Links

• Sponsor Web Page

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: August 17, 2006
• First Submitted That Met QC Criteria: August 17, 2006
• First Posted (Estimate): August 18, 2006

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: neoplasm; Fibroids; leiomyoma; benign tumors
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: UF018