ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids
The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids.
The ExAblate System is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. In this particular study, the targeted tissue is uterine fibroids. Each sonication is used to heat small spots in the fibroid much like a magnifying glass can be used to focus light to heat a spot. The heat created kills a portion of the fibroid with the goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are performed until the entire fibroid is treated or the treated volume is determined to be appropriate.
The ExAblate system is commercially approved in the United States to treat symptomatic uterine fibroids.
The ExAblate UF V2 System is an experimental device and is being investigated in this study. While similar to the commercial system, the ExAblate UF V2 device includes the following major changes, among others, which are intended to improve device performance and safety:
- Up and down movement of the ultrasound transducer, in an attempt to improve fibroid treatment by moving the ultrasound focal point within the targeted fibroid.
- Ultrasound energy can be turned off for a specific area in an attempt to minimize amount of energy passing through sensitive areas of the body.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Clinical Study to Evaluate Safety of the ExAblate Model 2100 Type 1.1 System (ExAblate 2100/2000 UF V2 System) in the Treatment of Symptomatic Uterine Fibroids|
- Leg pain or lower extremity neuropathy persisting or occuring greater than 10 days following treatment [ Time Frame: From treatment to 1-month post-treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
|Experimental: ExAblate treatment||
Device: ExAblate UF V2
Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period.
|United States, California|
|Stanford University Medical Center||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Fizaa Ahmed 650-725-6409 firstname.lastname@example.org|
|Sub-Investigator: Pejman Ghanouni, M.D.|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Louise Greenberg 617-732-5441 LGREENBERG@PARTNERS.ORG|
|Principal Investigator: Serene Srouji, M.D.|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Contact: Patty Johnson, RN 507-538-7765 FOCUSEDULTRASOUND@mayo.edu|
|Principal Investigator: Gina Hesley, MD|
|United States, Ohio|
|Ohio Health Research Institute||Recruiting|
|Columbus, Ohio, United States, 43214|
|Contact: Carol Strausbaugh, RN 614-566-1253 email@example.com|
|Principal Investigator: Eric Dolen, MD|
|United States, Virginia|
|University of Virginia Health System||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Brigitte Kelly 434-243-0315 BJK3C@hscmail.mcc.virginia.edu|
|Principal Investigator: Alan Matsumoto, MD|