A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptom… (NCT01092988) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids
France, Israel, Russia40 participantsStarted 2010-03
Plain-language summary
The first magnetic resonance-guided focused ultrasound (MRgFUS) treatment of uterine fibroid using the ExAblate 2000 system was performed in 2001. Since then, more than 5000 treatments were done in more than 60 different hospitals around the world. The experience accumulated in this novel treatment was collected by InSightec and implemented into software and hardware updates, clinical tips and guidelines, all aimed to improve the clinical results and their durability, while maintaining a high level of safety.
Based on extensive clinical experience and our internal research and development effort goals toward continuous improvement in ExAblate treatment safety and performance, limited changes have been made to the current ExAblate system. This modified ExAblate system version is designated as the ExAblate 2100 UF V2 system.
The modifications are believed to improve system's friendliness to the user, without introducing new risks or other issues of safety of the device, and should not have any negative impact on the safety or technical efficacy of the treatments for patients.
Who can participate
Age range18 Years
SexFEMALE
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)
✓. Able to communicate sensations during the ExAblate procedure.
✓. Uterine fibroids, which are device accessible
✓. Fibroid(s) clearly visible on non-contrast MRI.
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