Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

The use of the MRI-HIFU for the ablation of leiomyomas

Symphony MRI guided High Intensity Focused Ultrasound (HIFU)

David Elizabeth

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.

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

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

Safety will be 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 skin over the treatment volume.

Reduction of fibroid volume in milliliters

Measured by non-perfused volume in milliliters

Change in symptoms to be quantified by Symptom Severity Scores (SSS) derived from Uterine Fibroid Symptom and Quality of Life questionnaire.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas	NCT03323905	Leiomyoma Fibroid	Symphony MRI gu...	18 Years -	Sunnybrook Health Sciences Centre
Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas	NCT03323905	Leiomyoma Fibroid	Symphony MRI gu...	18 Years -	Sunnybrook Health Sciences Centre

Spots Global Cancer Trial Database for symphony mri guided high intensity focused ultrasound (hifu)