Clinical Case for Focused Ultrasound
This international study will test the safety and effectiveness of a new focused ultrasound system for treating uterine fibroids. Focused ultrasound provides a promising option for women who are seeking relief from uterine fibroid symptoms without having to undergo hysterectomy or other surgical procedures. Hysterectomy is currently the most common treatment for uterine fibroids, and it involves a long recovery time with many days lost from work and normal daily activities.The new system is manufactured by Philips Healthcare, and it is called the Sonalleve Focused Ultrasound system.
What is the Objective of the Study?
Although it has been approved for use in Europe, Asia, and South America since 2009, this study will test the safety and effectiveness of the Sonalleve system with the intention of gaining approval for use in the United States. It will also compare symptom resolution between women who get their fibroids treated with focused ultrasound vs. women who do not get treated.
What is Focused Ultrasound?
Focused ultrasound therapy uses magnetic resonance imaging (MRI) to guide the application of focused, high-intensity ultrasound waves through the skin down to the target tissue. The high-intensity sound waves are focused on the individual fibroids much like using a magnifying glass to focus the sun’s rays – only the focal point becomes hot enough to destroy the unwanted or problematic tissue. The MRI gives the treating physician a three-dimensional view of the uterus and fibroids and provides real-time feedback about the temperature and tissue changes that occur as each fibroid is ablated. Requiring no incision, no hospital stay, and allowing a rapid return to family or work, focused ultrasound offers women with symptomatic uterine fibroids a treatment option worth considering. Focused ultrasound has been approved by the FDA in the United States since 2004, and it has been used worldwide to treat more than 7,000 women. This clinical trial is testing Sonalleve, a new focused ultrasound system manufactured by Philips Healthcare.
Where is the Study Taking Place?
Who is Eligible for the Study?
To be eligible for this FDA- approved study, patients must be women aged 18 to 50 who have been diagnosed with symptomatic uterine fibroids. Participants in the study must be experiencing heavy menstrual bleeding, weigh less than 310 pounds (140 kg), and have a uterine size that is less than 24 weeks of a typical pregnancy. Women who participate in the study must be willing and able to undergo magnetic resonance imaging (MRI), undergo a Pap smear, complete a menstrual blood loss assessment, and use reliable methods of contraception.
Women who desire future pregnancy or who have other pelvic diseases are not allowed to participate.
Women who are interested in participating should contact the coordinator at the nearest site to determine if they are a potential candidate for this study.
What Can Participants Expect?
If accepted to participate in the study, patients will be randomly divided into two groups. The majority of the women will receive the focused ultrasound treatment, while a small subset of patients will go through the same procedure but receive a pretend treatment. Neither the clinical evaluator nor the patients will know whether the patient receives the actual or the pretend treatment. After a designated time period, women who have had no relief in symptoms may ask for and receive re-treatment. Patients who did not receive focused ultrasound initially will be provided the therapy. Participants will be followed for up to 3 years and will be expected to complete study questionnaires and other requirements during the duration of the study.
What is the Cost for the Treatment?
Participants do not pay for the treatment and patients successfully enrolled in the study will be compensated for their time and expenses.
Where Can I Find Additional Information?
More information about this study can be found at www.clinicaltrials.gov. A list of currently enrolling sites can be found on our website under Clinical Trials. Contact the study coordinator at any of the enrolling sites to determine whether you might be a match for this particular study and to ask questions specific to your interest in and ability to participate.
About Sonalleve and Philips Healthcare
The Sonalleve MR-HIFU system was developed and is manufactured by Philips Healthcare to treat uterine fibroids. It has been approved for use in Europe, Asia, and South America since 2009. The system uses non invasive high-intensity focused ultrasound (“HIFU”) that is guided by magnetic resonance (“MR”) imaging. Philips Healthcare aims to improve patient outcomes while lowering the burden on the healthcare system by creating advanced healthcare solutions for healthcare professionals and consumers that will meet the needs of patients in hospitals and at home.*
* Philips neither approves nor endorses this content