Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids
The objective of this trial is to evaluate the safety and efficacy of ExAblate for the treatment of uterine fibroids.
Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the study.Women who agree to participate will sign an informed consent and will be randomized to ExAblate treatment or myomectomy.
All patients will be followed through the 36 month visit. Follow-up visits/telephone calls will be completed at 1 week, 2 weeks, 6 weeks, 3 months, 6, 12, 18, 24 and 36 months post treatment.
Patients will be evaluated by assessing their overall physical and mental health as well as for device/procedure related adverse events.
Device: Exablate 2100
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for the Treatment of Uterine Fibroids|
- Safety [ Time Frame: 36 months post treatment ] [ Designated as safety issue: Yes ]Safety will be evaluated by recording and assessing the incidence and severity of major adverse events from treatment through the 3 years follow-up period.
- Efficacy [ Time Frame: 36 months post treatment ] [ Designated as safety issue: No ]Comparison between ExAblate treatment and non-Hysteroscopic Myomectomy in terms of treated patients who did not undergo another interventional treatment for recurrence of uterine fibroid symptoms at up to 36 months (3 years).
- Efficacy [ Time Frame: 36 months post treatment ] [ Designated as safety issue: No ]
- Post treatment change in patient's quality of life
- Post treatment change in pelvic pain
- Post treatment Change in bleeding
- Post treatment recovery time
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Treatment
MR guided Focused Ultrasound
Device: Exablate 2100
Active Comparator: Surgery