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

InSightec

Status and phase: Completed; Phase 3

Conditions: Uterine Fibroids; Uterine Leiomyomas

Treatments: Device: ExAblate 2000

Study type: Interventional

Funder types: Industry

Identifiers

NCT00295217

Continued Access

UF017

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)