%0 Case Reports
%T Safety of a 1064-nm robotic laser system for noninvasive lipolysis of the flanks.
%A Fiala T
%A Lavin P
%J Lasers Surg Med
%V 54
%N 5
%D 07 2022
%M 35266172
暂无%R 10.1002/lsm.23532
%X The primary objective of this pilot study was to confirm the safety of a 1064-nm laser device with a novel robotic arm for noninvasive subcutaneous fat reduction in the flank area. Secondary objectives included: assessing the extent of subject discomfort during treatment, overall subject satisfaction with the results of the procedure, and a determination of subcutaneous fat reduction in the treated area, in preparation for larger upcoming trials.<BR>A 110-cm2 area on both flanks of enrolled subjects (N = 11; 22 flanks) was treated for 20 minutes with a Food and Drug Administration-cleared robotic noncontact 1064-nm laser system (EON®; Dominion Aesthetic Technologies, Inc.). Patients were followed for 12 weeks, and examined routinely at 2 weeks, 12 weeks, and additionally as needed, posttreatment. Ad hoc surveys were administered to assess patient satisfaction. A 2-week posttreatment ultrasound scan was used to check for changes in the treated area. Ultrasound measurements were also used to determine the subcutaneous adipose tissue thickness at a center of each treatment zone before treatment and at 12 weeks posttreatment for efficacy determination, with mean thicknesses calculated per subject.<BR>The treatment had a low incidence of adverse effects, with only one subject developing a palpable thickening in the subcutaneous tissue following treatment. This was noted at the 2-week time period and had resolved by the 12-week posttreatment exam. No other predefined adverse effects were noted. On a scale of 0-10, the mean pain score during the procedure was 1.95, decreasing to 0.9 at 30 minutes postprocedure. Subject satisfaction was "Excellent" for all subjects (100%). At Week 12 after one treatment, the mean reduction in subcutaneous adipose thickness on the treated flanks was 6.1 mm per patient (-15%; p < 0.01).<BR>Similar to a prior abdominal study with the same robotic laser device, this pilot study confirms the safety of this 1064-nm noncontact laser device for treating subcutaneous fat on the flanks. The procedure is well tolerated with a high degree of subject satisfaction. The amount of subcutaneous fat reduction in the flank area appears similar to that seen in the abdomen, but larger studies are required for confirmation.<BR>gov Identifier: NCT04797988.