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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

HIFUSB Trial Summary

This trial will help determine if a new treatment for leiomyomas, which are growths in the uterus, is effective and safe. The treatment uses MRI-guided focused ultrasound to heat and destroy the leiomyomas. The trial will measure the fibroid size and symptom severity score before and after the treatment to see if there is a reduction.

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.Check my eligibility

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.See study design

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.

HIFUSB Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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)

HIFUSB Trial Design

1Treatment groups

Experimental Treatment

Group I: MR Guided High Intensity Focused UltrasoundExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,550,572 Total Patients Enrolled

Sunnybrook Research InstituteOTHER

31 Previous Clinical Trials

215,769 Total Patients Enrolled

Arrayus Technologies Inc.UNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining slots open for potential participants in this research study?

"This study, which was first uploaded to clinicaltrials.gov on November 16th 2017 and last updated on August 24th 2022 is not presently recruiting patients. However, 47 other medical trials are actively accepting participants at this time."

Answered by AI