The safety and efficacy of thermal lipolysis of adipose tissue via ultrasound for circumference reduction: An open label, single-arm exploratory study.

ABSTRACT

BACKGROUND AND OBJECTIVE: To better understand adipocyte sensitivity under hyperthermic conditions, the ULTIMA system (also known as MUST) was designed to induce the thermal destruction of fat cells using ultrasound, radiofrequency, and vacuuming. This clinical study assessed the safety and efficacy of ULTIMA in non-invasive reductions of abdominal circumference. STUDY DESIGN: This open-label, single-arm exploratory study monitored the response of 21 patients to a single fat reduction treatment session with the ULTIMA system. Male and female patients between the ages of 18 and 65 who presented with a subcutaneous adipose fat thickness >2.5 cm as measured with a caliper and 2 cm as measured by ultrasound were eligible to participate in the study. Patients with a history of surgery in the target region and who had previous fat/circumference reduction treatments within the previous 6 months were excluded. Efficacy measures evaluated at the 1-, 2-, and 3-month post-treatment visits included the following photographs of before and after treatment as evaluated by two blinded reviewers, changes from the baseline abdominal circumference and fat layer thickness, and subjective physician and patient assessments. Immediate skin responses were recorded for up to 30 minutes post-treatment, and adverse events were recorded throughout the study. RESULTS: An average of 10 zones per patient were subjected to ULTIMA treatment and 87.5% of the pre-treatment photographs were correctly rated by two independent blinded reviewers. A statistically and clinically significant reduction in the abdominal circumference was observed at 3 months post-treatment. The changes in circumference (represented as the mean ± SE) of the baseline of the anterior superior iliac spine (ASIS), umbilicus, and maximal circumference during this period were -3.2 ± 0.7 cm, -3.9 ± 0.7 cm, and -3.3 ± 0.8 cm, respectively. Physician-based assessments classified all patients (100%) as "improved" within 3 months of treatment, and self-assessment questionnaires completed by the patients demonstrated that 92% of them classified their conditions as either improved or much improved within this same time period. Any immediate skin reactions observed fell within the expected norms and were short-lived and self-resolving. CONCLUSIONS: A single ULTIMA treatment session effectively and safely resulted in visual appearance improvement and in a significant reduction in the patients' abdominal circumference, which persisted for 3 months. Additional investigations will be required to further optimize the treatment regimen and assess its long-term sustainability. Lasers Surg. Med. 48734-741, 2016. © 2016 Wiley Periodicals, Inc.