Ultrasound System for the Treatment of Leiomyomas
common.study.values.description
“Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas”
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.
common.study.values.location
participant.ui.study.affiliations-map.online-study.header-virtual
participant.ui.study.affiliations-map.online-study.text
common.study.values.methods
common.study.methods.has-drugs-no
common.study.methods.is-healthy-yes
Device - Symphony MRI guided High Intensity Focused Ultrasound (HIFU)
The use of the MRI-HIFU for the ablation of leiomyomas
participant.views.study.view.additional
participant.views.study.view.scientific-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
common.study.values.clinical-trial-id
NCT03323905
participant.views.study.view.id
Pdy3wa
