Clinical trial NCT00295217: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation
Official title: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Clinical Study to Validate the Changes to ExAblate 2000 Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Fibroids
Uterine Leiomyomas
Keywords: Fibroids
Uterine Leiomyomas
ExAblate
MrgFUS
Lead sponsor: InSightec
Sponsor class: INDUSTRY
First posted: 2006-02-23
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
Secondary outcomes:
Other outcomes:
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
Study officials:
affiliation: Lahey Clinic
name: George Holland, 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: University of California, San Diego
name: Anne Roberts, M.D.
role: PRINCIPAL_INVESTIGATOR
References: