Non-Invasive Body Contouring by Focused Ultrasound: Safety and Efficacy of the Contour I™ Device in a Multi-Center Controlled Clinical Study

Steven A. Teitelbaum, MD, FACS, John L. Burns, MD, Junichiro Kubota, MD, Hidenori Matsuda, MD, Morkel J. Otto, MBChB, MPharm Med, M Phil Medical Law, Yukio Shirakabe, MD, Yoshiro Suzuki, MD, Spencer A. Brown PhD

ABSTRACT

Background: The removal of unwanted body fat using a non-invasive technique is desirable to patients and physicians. We describe a controlled multi-center clinical trial assessing the safety and efficacy of a focused therapeutic ultrasound device for non-invasive body contouring.

Methods: Eligible healthy adult subjects were enrolled to the experimental or the control group at five sites. The experimental group received one treatment with the Contour I™ device (UltraShape Ltd., Israel) in the abdomen, thighs, or flanks and were evaluated over a 12 week period. Efficacy outcomes were reduction of circumference and fat thickness. Circumference reduction was compared to the untreated group and to an untreated area (thigh) within the treated group. Safety monitoring included laboratory testing (including serum lipids), pulse oximetry, and liver ultrasound.

Results: One hundred and sixty four subjects participated in the study (137 subjects in the experimental group and 27 in the control (untreated) group. A single Contour I™ treatment was safe, well tolerated, and produced a mean reduction of ~2 cm in treatment area circumference and ~2.9 mm in skin fat thickness. The majority of the effect was achieved within two weeks and was sustained at 12 weeks. No clinically significant changes in the measured safety parameters were recorded. Seven adverse events were reported, all of which were anticipated, mild, and resolved within the study period.

Conclusions: The Contour I™ device provides a safe and effective non-invasive technology for body contouring

INTRODUCTION

Body contouring by liposuction is the most frequently performed cosmetic surgery procedure in the United States, with an estimated 455,000 cases in 2005.1 This number represents less than 1% of the potential pool: 45 million Americans diet every year to improve health and enhance body contour, and even this is a small portion of the one hundred and thirty million Americans who are overweight.2, 3 Liposuction methodology has evolved over several decades to yield a procedure that is safer, amenable to regional anesthesia or conscious sedation, and can be performed in an outpatient setting.4-7 Despite the many advances in the liposuction technique, it retains risk and discomfort by virtue of its invasive nature, and post-procedure recovery may require extensive downtime and compression garments.8 In addition, even when clinically well-tolerated, hemodynamic and metabolic changes occur in the immediate post-surgical days.9-13

Ultrasound-assisted liposuction (UAL) accounted for 21% of liposuction procedures in 2005.1 Internally-applied ultrasound improves the liposuction technique by disrupting adipose tissue.14-18 This advantage is offset to some degree by the increased technical skill required and the increased risk of injury to the skin at sites of direct contact between the probe and the skin, due to the thermal effects of the currently available ultrasonic probes.

Existing non-invasive and minimally-invasive technologies for improving the appearance of skin and subcutaneous fat appearance, such as deep body massage, radiofrequency, and light-based treatments, have gained popularity due to their minimal downtime, relative safety, and cosmetic benefit in temporary reduction in the appearance of cellulite.19-22 However, they are suboptimal for body contouring as they provide only modest and temporary circumference reduction, require multiple treatments for effect, provide short-term results, and may require maintenance therapy. Their use is therefore limited to treatment of the superficial subcutaneous layer for temporary reduction in the appearance of cellulite.23-25 Furthermore, unlike liposuction, they do not aim to remove excess subcutaneous fat, but rather to tighten the overlying skin or to improve circulation, with theorized secondary effects of reducing edema and mobilizing intracellular fat by inducing biochemical lipolysis in intact adipocytes. There is a need for a technology that provides improved durability.

A method of delivering ultrasound to the fat without depositing significant ultrasound energy in the skin would provide the benefits of ultrasound disruption of fat with greater safety. Furthermore, an ideal non-invasive method of delivering energy would reduce periprocedural morbidity such as infection, scarring, anesthesia-related complications, and other risks associated with surgical procedures.

We describe here the pivotal clinical trial which demonstrates the safety and efficacy of the Contour I™ (UltraShape Ltd., Israel), a non-invasive device for body contouring. This device utilizes pulsed ultrasound at parameters designed to produce non-thermal effects in the subcutaneous fat.

1301 Twentieth Street, Suite 350, Santa Monica, Calif. 90404-1208

Click here to read more on the Contour I^TM