Phase 3 Completed N=50 Treatment

MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication

Uterine Fibroids

Source: ClinicalTrials.gov NCT00365989 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcomePrimary: Number of Adverse Events — 77; 75 Adverse Events

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Adverse Events	77; 75	—

Eligibility Criteria

Inclusion Criteria

Women age 18 or older, who present with symptomatic fibroids
Women who have given written informed consent
Women who are able and willing to attend all study visits.
Patient is pre or peri-menopausal (within 12 months of last menstrual period).
Able to communicate sensations during the ExAblate procedure.
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).
Fibroids(s) clearly visible on non-contrast MRI.

Exclusion Criteria

Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment
Patient who desire to become pregnant in the future.
Patients who are breast-feeding.
Patients with an active pelvic inflammatory disease (PID)
Active local or systemic infection
Metallic implants that are incompatible with MRI
Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)
Severe claustrophobia that would prevent completion of procedure in the MR unit.
Extensive abdominal scarring in the beam pass or dermoid cyst of the ovary anywhere in the treatment path.
Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
Pedunculated fibroids.
Intrauterine device (IUD) anywhere in the treatment path
Undiagnosed vaginal bleeding.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00365989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.