MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation

Uterine Fibroids Clinical Trial

Official title:

MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Clinical Study to Validate the Changes to ExAblate 2000 Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00295217
• Other study ID #: UF017
• Secondary ID: Continued Access
• Status: Completed
• Phase: Phase 3
• Start date: February 2006
• Est. completion date: October 2006

Study information

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

Clinical Trial Summary

The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment. The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.

2. Able and willing to give consent and able to attend all study visits.

3. Patient is pre or peri-menopausal (within 12 months of last menstrual period).

4. Able to communicate sensations during the ExAblate procedure.

5. 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).

6. Fibroids(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

1. Metallic implants that are incompatible with MRI

2. Sensitive to MRI contrast agents

3. Severe claustrophobia that would prevent completion of procedure in MR unit

4. Who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.

5. Pedunculated fibroids

6. Active pelvic inflammatory disease (PID)

7. Active local or systemic infection

8. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia

9. Intrauterine device (IUD) anywhere in the treatment path

10. Dermoid cyst of the ovary anywhere in the treatment path

11. Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries)

12. Undiagnosed vaginal bleeding

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids
• Uterine Leiomyomas

Intervention

Device:
• ExAblate 2000

Locations

Country	Name	City	State
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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In this IDE for the 4.2 ExAblate system, the goal is evaluation of the new features to confirm that they do not introduce any new safety issues.

External Links

•   Sponsor web page