Safety Study of ExAblate for the Treatment of Uterine Fibroids (NCT01142791) | Clinical Trial Compass
CompletedNot Applicable
Safety Study of ExAblate for the Treatment of Uterine Fibroids
United States121 participantsStarted 2010-05
Plain-language 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 treatment guidelines. Treatment may include up to 100% of individual fibroid volume, within established serosal and sacral treatment margins.
The Enhanced sonication is one of the various sonication modes that may lead to increased thermal dose volume of each sonication without additional safety risks. This is an additional treatment tool available in the ExAblate system for the treatment of uterine fibroids.
The safety profile of the Enhanced Sonication was investigated under an FDA-regulated IDE study. FDA granted approval of Enhanced Sonication with the requirement to perform a post-approval study to collect additional safety data when treating up to 100% of individual fibroid volume.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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)
* A…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent Occurrence of Chronic Leg Pain
Timeframe: From treatment to 1-month post-treatment