Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas
(HIFUSB Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a new device that uses MRI and focused ultrasound waves to treat uterine fibroids. It aims to see if this method can effectively reduce fibroid size and symptoms in patients. The study will also check if the treatment is safe. This technique has a history of being used to reduce fibroid size and symptoms.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on anti-coagulation therapy, you may not be eligible to participate.
Is Symphony MRI guided High Intensity Focused Ultrasound (HIFU) generally safe for humans?
Research on high-intensity focused ultrasound (HIFU) for conditions like uterine fibroids, prostate cancer, and pancreatic cancer shows that it has been studied for safety. While specific adverse events (unwanted side effects) can occur, these studies suggest that HIFU is generally considered safe for human use in these conditions.12345
How does Symphony MRI guided High Intensity Focused Ultrasound (HIFU) treatment differ from other treatments for this condition?
Symphony MRI guided High Intensity Focused Ultrasound (HIFU) is unique because it is a non-invasive treatment that uses focused ultrasound waves to heat and destroy targeted tissue, guided by real-time MRI imaging. This allows for precise targeting of tumors or other conditions without the need for surgery, making it a promising alternative to traditional treatments like surgery or radiation.678910
What data supports the effectiveness of the treatment Symphony MRI guided High Intensity Focused Ultrasound (HIFU)?
Research shows that MRI-guided High Intensity Focused Ultrasound (HIFU) is a promising non-invasive treatment for various tumors, including those in the prostate, breast, and brain. It has been tested for safety and feasibility in several studies, suggesting it could be an alternative or addition to traditional cancer treatments like surgery and chemotherapy.710111213
Who Is on the Research Team?
David Elizabeth
Principal Investigator
Sunnybrook Reserach Institute
Are You a Good Fit for This Trial?
This trial is for pre- or peri-menopausal women under 310 lbs with uterine fibroids, who can use contraception and attend all visits. They should have a waist less than 43 inches, fibroids accessible by the MRI-HFU device, and no extensive scarring or tattoos that could interfere with treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo MRI-guided high intensity focused ultrasound ablation of leiomyomas
Follow-up
Participants are monitored for safety and effectiveness after treatment, including reduction in fibroid size and symptom severity
What Are the Treatments Tested in This Trial?
Interventions
- Symphony MRI guided High Intensity Focused Ultrasound (HIFU)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sunnybrook Health Sciences Centre
Lead Sponsor
Arrayus Technologies Inc.
Industry Sponsor
Sunnybrook Research Institute
Collaborator
Arrayus Technologies Inc.
Collaborator