An Open-label, Single-center, Prospective Evaluation of a Novel Noninvasive Ultrasound Body Sculpting Device

摘要

Objective: The goal of this study was to evaluate the safety and the efficacy of the SlimME? (Lumenis AB, Lumenis, Israel) ultrasound device for noninvasive body contouring. Design: This was an open-label, single-arm, exploratory study. Participants: Twenty adult patients presenting with subcutaneous target region adipose fat thickness greater than 2.5cm were included in this study. Measurements: Responses to a single treatment session with the ultrasound device were assessed. Change from baseline in abdominal circumference was evaluated at one, two, and three months posttreatment. Before and after treatment, the physician scored improvements, patients completed a self-improvement assessment questionnaire, and photographs were evaluated by three blinded reviewers. Immediate skin responses were recorded for up to 30 minutes posttreatment, and adverse events were recorded throughout the study. Results: A statistically and clinically significant reduction in abdominal circumference was observed at three months posttreatment, with a mean of -2.19±1.95cm, -2.14±1.94cm, and -1.83±2.00cm reduction from baseline in the umbilicus, under the ribs, and anterior superior iliac spine (ASIS) circumference measurements, respectively. Physician-based assessments classified 89.5 percent of subjects as “improved” within three months of treatment, and 89.5 percent of patients indicated their conditions to be either improved or much improved within this same time period. Immediate skin reactions were all expected, short-term, and self-resolving. Conclusions: A single treatment session using the ultrasound study device appears safe and effective in achieving noninvasive body contouring.