MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication

Uterine Fibroids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365989
• Other study ID #: UF018
• Status: Completed
• Phase: Phase 3
• Start date: October 2006
• Est. completion date: August 2008

Study information

• Verified date: December 2018
• Source: InSightec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids
• Uterine Leiomyoma

Intervention

Device:
• ExAblate Enhanced Sonication

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario
United States	Lahey Clinic	Burlington	Massachusetts
United States	KNI	Kalamazoo	Michigan
United States	University of California at San Diego	La Jolla	California
United States	Cornell Vascular	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Number of Participants With Adverse Events		Within 1 month of treatment
Primary	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

External Links

•   Sponsor web page