Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas

Official Title

MRI-guided High Intensity Focused Ultrasound Ablation of Leiomyomas. Single Arm, Feasibility Study Using the Symphony - MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas

Summary:

Single arm, first-in human feasibility study using the Symphony - MRI guided focused ultrasound system for the treatment of leiomyomas. The study is expected to accrue over 12 months. This study will help determine the feasibility to ablate leiomyomas, as measured by MR thermometry and contrast enhanced imaging. In addition, the study will look at the efficacy and safety of the treatment, as measured by the reduction in fibroid size and reduction in symptom severity score and adverse events. This study will help develop future pivotal trials using the same device.

Trial Description

Primary Outcome:

• The ability to ablate fibroid tissue measured by temperature elevation
• The ability to ablate fibroid tissue indicated by Non-Perfused Volume (NPV)
• Safety of the system measured by collection of adverse events related to potential damage to tissue outside the treatment zone
• Safety of the system based on damage to skin measured by collection of adverse events related to potential damage to skin over the treatment volume

• Treatment efficacy to reduce fibroid size
• Treatment efficacy to reduce fibroid size by NPV
• Treatment efficacy to reduce symptom severity by Symptom Severity Scores (SSS)

View this trial on ClinicalTrials.gov