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High Intensity Focused Ultrasound

Symphony MRI guided High Intensity Focused Ultrasound (HIFU) for Uterine Fibroids (HIFUSB Trial)

N/A
Waitlist Available
Led By David Elizabeth
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
The study tests the Symphony MRI-guided High Intensity Focused Ultrasound (HIFU) system on leiomyomas (fibroids). It aims to see if this method can safely shrink fibroids and reduce symptoms without surgery over a period of 12 months.
What are the potential side effects?
Potential side effects may include discomfort from lying prone during treatment, skin burns due to ultrasound exposure, pain or cramping post-treatment, and possible injury to surrounding tissues or organs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 of the system measured by collection of adverse events related to potential damage to tissue outside the treatment zone
Body tissue
+1 more
Secondary study objectives
Treatment efficacy to reduce fibroid size
Treatment efficacy to reduce fibroid size by NPV
Treatment efficacy to reduce symptom severity by Symptom Severity Scores (SSS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: MR Guided High Intensity Focused UltrasoundExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Symphony MRI guided High Intensity Focused Ultrasound (HIFU)
2017
N/A
~50

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
MRI-guided focused ultrasound ablation (FUS) treats uterine fibroids by using high-intensity ultrasound waves to generate localized heat, which destroys fibroid tissue while sparing surrounding healthy tissue. This non-invasive method is guided by MRI to precisely target fibroids, reducing symptoms like heavy bleeding and pelvic pain. Other common treatments include hormonal therapies, which shrink fibroids by altering hormone levels, and surgical options like myomectomy or hysterectomy, which physically remove fibroids. Understanding these mechanisms helps patients choose treatments based on factors like invasiveness, recovery time, and potential impact on fertility.

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor
673 Previous Clinical Trials
1,565,817 Total Patients Enrolled
Sunnybrook Research InstituteOTHER
31 Previous Clinical Trials
215,735 Total Patients Enrolled
Arrayus Technologies Inc.UNKNOWN
~6 spots leftby Oct 2025