Clinical Study of the Mirabilis High-Intensity Focused Ultrasound System for Non-Invasive Treatment of Uterine Fibroids
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01946178|
Recruitment Status : Completed
First Posted : September 19, 2013
Results First Posted : March 25, 2016
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment|
|Uterine Fibroids (Leiomyomas)||Device: Mirabilis High-Intensity Focused Ultrasound Treatment System|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of a Focused Ultrasound Device for Treating Uterine Fibroids and Menorrhagia|
|Study Start Date :||January 2011|
|Primary Completion Date :||May 2015|
|Study Completion Date :||May 2015|
Experimental: Focused ultrasound treatment
Patients in this arm will receive fibroid treatment using the Mirabilis High-Intensity Focused Ultrasound Treatment System.
Device: Mirabilis High-Intensity Focused Ultrasound Treatment System
The intervention consists of a treatment session with the device, during which focused ultrasound energy is applied across the intact abdominal wall to ablate appropriately selected uterine fibroids under ultrasound imaging guidance.
- Evaluation of All Adverse Events Encountered [ Time Frame: Adverse Events were monitored until the patient's exit from the study (up to 6 months post-treatment). ]Safety of the treatment was determined by evaluating the incidence of Adverse Events and Adverse Device Effects. Adverse Device Effects are Adverse Events that are related to treatment with the device. Relatedness of an Adverse Event to the treatment was determined on a case-by-case basis by the investigator. The average number of Serious Adverse Device Effects per patient and the average number of Non-Serious Adverse Device Effects per patient are reported to provide numeric outcomes of this evaluation.
- HIFU-related Non-Perfused Volume (NPV) [ Time Frame: The NPV was measured between 0 and 7 days post-treatment. ]Efficacy of the treatment was quantified by measuring the HIFU-related Non-Perfused Volume (NPV) of tissue in each patient using either post-treatment contrast-enhanced magnetic resonance imaging (MRI) or pathology assessment following hysterectomy. The NPV is used to measure the amount of tissue that was treated during the procedure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946178
|Hospital Torre Medica|
|Ciudad de Mexico, Distrito Federal, Mexico, 06030|
|Hospital Universitario, Universidad Autonoma de Nuevo Leon|
|Monterrey, Nuevo Leon, Mexico, 64460|
|Study Director:||Michael Lau, M.D.||Mirabilis Medica, Inc.|