Status:
COMPLETED
Safety Study of ExAblate for the Treatment of Uterine Fibroids
Lead Sponsor:
InSightec
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatm...
Eligibility Criteria
Inclusion
- Women age 18 or older
- Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher, based on patient responses to questions 1-8 of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)
- 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).
- Patient should be family complete.
- 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.
- Fibroid enhances on MR contrast imaging.
Exclusion
- Women who are pregnant, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment.
- Patients who are breast-feeding.
- Patients with active pelvic inflammatory disease (PID).
- Patients with active local or systemic infection.
- Patients experiencing chronic leg or lower back pain within the last 6 months.
- Contraindication for MRI Scan:
- Severe claustrophobia that would prevent completion of procedure in the MR unit
- Weight greater than 250 lbs (113Kg)
- Implanted ferromagnetic materials and/or devices contraindicated for MR scan
- Known intolerance to MRI contrast agent (e.g. Gadolinium or Magnevist)
- Any other contraindication for MRI Scan
- Extensive abdominal scarring in the beam path (that cannot be avoided by redirection of the beam).
- Dermoid cyst of the ovary anywhere in the treatment path.
- Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
- Intrauterine device (IUD) anywhere in the treatment path.
- Undiagnosed vaginal bleeding.
- Pedunculated fibroids.
- Uterine size \>24 weeks.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01142791
Start Date
May 1 2010
End Date
April 1 2012
Last Update
March 19 2019
Active Locations (8)
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1
UCLA
Los Angeles, California, United States, 90095
2
UCSD Department of Radiology
San Diego, California, United States, 92103-8749
3
University of California San Francisco
San Francisco, California, United States, 94107
4
University Image Guided Therapy
Boca Raton, Florida, United States, 33431