这项初步研究的主要目的是确认具有新型机械臂的1064nm激光设备的安全性,以减少侧腹区域的皮下脂肪。次要目标包括:评估治疗期间受试者不适的程度,受试者对程序结果的总体满意度,并确定治疗区域的皮下脂肪减少,为即将到来的更大试验做准备。
用食品和药物管理局清除的机器人非接触式1064-nm激光系统(EON®;DominionAestheticTechnologies,对登记受试者的两侧(N=11;22侧)的110-cm2面积进行了20分钟的处理。Inc.).患者随访12周,并在2周进行常规检查,12周,此外,根据需要,后处理。进行临时调查以评估患者满意度。治疗后2周超声扫描用于检查治疗区域的变化。超声测量还用于确定治疗前和治疗后12周每个治疗区中心的皮下脂肪组织厚度,以确定疗效。计算每个受试者的平均厚度。
该治疗的不良反应发生率低,治疗后,只有一名受试者在皮下组织中出现明显的增厚。这在2周的时间段被注意到,并且通过12周的治疗后检查已经解决。没有注意到其他预定义的不良反应。在0-10的范围内,手术过程中的平均疼痛评分为1.95,术后30分钟降至0.9。所有受试者的满意度均为“优秀”(100%)。一次治疗后第12周,治疗侧翼的皮下脂肪厚度平均减少6.1mm/患者(-15%;p<0.01).
类似于先前使用相同机器人激光设备的腹部研究,这项初步研究证实了这种1064nm非接触式激光装置用于治疗侧翼皮下脂肪的安全性.该程序耐受性良好,受试者满意度高。侧腹区域的皮下脂肪减少量似乎与腹部相似,但需要更大规模的研究来确认。
gov标识符:NCT04797988。
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.
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.
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).
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.
gov Identifier: NCT04797988.