Clinical trial NCT00365989: MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication
Official title: A Clinical Study To Evaluate the Safety and Efficacy of MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Leiomyoma
Uterine Fibroids
Keywords: Fibroids
leiomyoma
neoplasm
benign tumors
Lead sponsor: InSightec
Sponsor class: INDUSTRY
First posted: 2006-08-18
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: Within 1 month of treatment
Secondary outcomes:
Other outcomes:
measure: Mean Enhanced Sonication Normalized Thermal Dose Volume
timeFrame: During treatment
measure: Number of Participants With Adverse Events
timeFrame: Within 1 month of treatment
Locations:
city: La Jolla
country: United States
facility: University of California at San Diego
state: California
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Kalamazoo
country: United States
facility: KNI
state: Michigan
city: New York
country: United States
facility: Cornell Vascular
state: New York
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University of California, San Diego
name: Anne Roberts, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: KNI
name: Mark Shaman, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Cornell
name: Robert Min, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto General Hospital
name: David Gianfelice, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Lahey Clinic
name: George Holland, M.D.
role: PRINCIPAL_INVESTIGATOR
References: