What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for uterine fibroids include medical therapies, surgical options, and minimally invasive procedures like MRI-guided focused ultrasound ablation. Medical therapies, such as GnRH analogs, can cause side effects like hot flashes, bone loss, and mood changes. Surgical options, including myomectomy and hysterectomy, carry risks of infection, bleeding, and complications related to anesthesia. MRI-guided focused ultrasound ablation, a non-invasive treatment, may cause temporary pain, skin burns, and nerve damage, but generally has fewer side effects compared to surgical options. Patients should discuss these potential side effects with their doctor to choose the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for uterine fibroids, including MRI-guided focused ultrasound ablation, which is a non-invasive procedure that uses high-intensity ultrasound waves to heat and destroy fibroid tissue. Additionally, medications such as selective progesterone receptor modulators (e.g., ulipristal acetate) and gonadotropin-releasing hormone (GnRH) antagonists (e.g., elagolix) have been approved to manage symptoms associated with fibroids. These treatments offer alternatives to surgical options like myomectomy and hysterectomy.

What other types of research exist?

Promising alternatives to the Symphony - MRI guided focused ultrasound system for treating uterine fibroids include hysteroscopic myomectomy, which involves the removal of fibroids using a hysteroscope. This method has been shown to be effective and safe, with advancements in techniques such as hysteroscopic morcellation improving outcomes. Additionally, laparoscopic management and other minimally invasive surgical techniques are also viable options.

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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 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

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

Do I qualify?Apply below to find out

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.