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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00295217

Enrollment

Registered

2006-02-23

Start date

2006-02-28

Completion date

2006-10-31

Last updated

2018-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Fibroids, Uterine Leiomyomas

Keywords

Fibroids, Uterine Leiomyomas, ExAblate, MrgFUS

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.

Interventions

DEVICEExAblate 2000

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026