A Clinical Study To Evaluate the Safety and Efficacy of MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
18 Years
N/A
Female
Uterine Leiomyoma, Uterine Fibroids
Trial Information
A Clinical Study To Evaluate the Safety and Efficacy of MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary end point is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.
Outcome Time Frame:
Within 1 month of treatment
Safety Issue:
No
Principal Investigator
Anne Roberts, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, San Diego
Authority:
United States: Food and Drug Administration
Study ID:
UF018
NCT ID:
NCT00365989
Start Date:
October 2006
Completion Date:
August 2008
Related Keywords:
- Uterine Leiomyoma
- Uterine Fibroids
- Fibroids
- leiomyoma
- neoplasm
- benign tumors
- Leiomyoma
- Myofibroma
Name | Location |
|---|---|
| University of California at San Diego | La Jolla, California 92093 |
| Lahey Clinic | Burlington, Massachusetts 01805 |
| Cornell Vascular | New York, New York 10022 |
| KNI | Kalamazoo, Michigan 49048 |
