NCT03323905

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leiomyoma
• Fibroid

Interventions

Type	Name	Description
DEVICE	Symphony MRI guided High Intensity Focused Ultrasound (HIFU)	The use of the MRI-HIFU for the ablation of leiomyomas

Timeline

• Start date: 2017-11-16
• Primary completion: 2023-12-01
• Completion: 2024-03-03
• First posted: 2017-10-27
• Last updated: 2024-07-09

Locations

1 site across 1 country: Canada