CompletedPhase 3

MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication

United States, Canada50 participantsStarted 2006-10

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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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.

What they're measuring

Number of Adverse Events

Timeframe: Within 1 month of treatment

Trial details

NCT IDNCT00365989

SponsorInSightec

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-08

Results submitted2018-12-20

View on ClinicalTrials.gov More Uterine Leiomyoma trials