An interventional study of Symphony MRI guided High Intensity Focused Ultrasound (HIFU) in Leiomyoma and Fibroid, sponsored by Sunnybrook Health Sciences Centre. Completed at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-09.
Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Treatment
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.
496 studies on the registry are indexed under Leiomyoma; 79 are open to participants now.
This study's enrollment of 50 is below the median of 62 across 350 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →Sunnybrook Health Sciences Centre is the lead sponsor of 582 studies on the registry; 133 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Fibroids selected for treatment meet the following criteria
Exclusion Criteria:
Device: Symphony MRI guided High Intensity Focused Ultrasound (HIFU)
The use of the MRI-HIFU for the ablation of leiomyomas
The ability to ablate fibroid tissue measured by temperature elevation
Measured by MRI thermometry
Time frame: 1 year
The ability to ablate fibroid tissue indicated by Non-Perfused Volume (NPV)
Measure by contrast enhanced imaging
Time frame: 1 year
Safety of the system measured by collection of adverse events related to potential damage to tissue outside the treatment zone
Safety will be measured by collection of adverse events related to potential damage to tissue outside the treatment zone.
Time frame: 1 year
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
Safety will be measured by collection of adverse events related to potential damage to skin over the treatment volume.
Time frame: 1 year
Treatment efficacy to reduce fibroid size
Reduction of fibroid volume in milliliters
Time frame: 1 year
Treatment efficacy to reduce fibroid size by NPV
Measured by non-perfused volume in milliliters
Time frame: 1 year
Treatment efficacy to reduce symptom severity by Symptom Severity Scores (SSS)
Change in symptoms to be quantified by Symptom Severity Scores (SSS) derived from Uterine Fibroid Symptom and Quality of Life questionnaire.
Time frame: 1 year
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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