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Barel et al.                                                                                                                                                                                          Ultrasound body contouring

           Table 2: Circumference changes from baseline by day and study group in treatment area
                                                                                       2
                                                     2
            Change from       High power (Isppa 440 W/cm )      Low power (Isppa 370 W/cm )   Weight differences
                                                                                               between groups
            baseline
                          Number Mean (cm)   SE     P value  Number Mean (cm)  SE     P value     P value
            Day 14          19      -1.54    0.57    0.016    17      -0.39    0.24    0.113       0.8741
            Day 28          19      -1.65    0.42   < 0.001   17      -0.87    0.33    0.019       0.9317
            Day 56          19      -2.14    0.60    0.002    17      -1.62    0.36   < 0.001      0.9981
            Day 84          19      -2.56    0.63   < 0.001   17      -1.49    0.52    0.012       0.9896
           Table 3: Circumference changes from baseline by day and study group in control area (untreated thighs)
                                                                                                     2
                                                             2
                                      High power (Isppa 440 W/cm )            Low power (Isppa 370 W/cm )
            Change from baseline
                                Number   Mean (cm)    SE      P value   Number   Mean (cm)    SE      P value
            Day 14                 19       0.32      0.31     0.316      17       -0.02     0.24      0.933
            Day 28                 19       0.47      0.37     0.214      17        0.17     0.24      0.484
            Day 56                 19       0.60      0.26     0.033      17        0.60     0.42      0.176
            Day 84                 19       1.08      0.32     0.003      17        1.25     0.48      0.019

           Table 4: Results of subject satisfaction feedback questionnaire
                                                    Day 28               Day 56                Day 84
            Questions in questionnaire
                                              High power  Low power  High power  Low power  High power  Low power
            Subjects reported favorable change in body   27.8%  41.2%  61.1%   64.7%      68.4%      58.8%
            contour since beginning of study
            Subjects reported receiving comments from   27.8%  41.2%  72.2%    70.6%      57.9%      70.6%
            other people regarding their appearance
            Subjects reported to recommend this   77.8%  76.5%      72.2%      76.5%      68.4%      70.6%
            procedure to their friends
            Subjects reported to prefer the Contour I™
            treatments over a short-term body contouring   66.7%  70.6%  66.7%  64.7%     89.5%      70.6%
            procedure    Electric power 160 W                 treatment, 84.2% after the second treatment, and



                                                              84.2% after the third; corresponding values in the
                         (6,720 mg)
               1.2
               1.0
             Internal control  circumference changes (cm) 1.4  Electric power 270 W   low-power group were 94.1%, 82.3%, and 88.2%.
                                                              “Unbearable” pain sensation was uncommon across all
               0.8
                         (8,000 mg)
                                                              treatments and modalities. “Unbearable” pain sensation
               0.6
                                                              at all 3 sessions was reported by one subject in the
               0.4
                                                              low-power group, at the first session by 2 subjects in
               0.2
               0.0
                                                              sessions by one subject in the high-power group. All
               -0.2  Baseline         14               28              56             84  the high-power group, and at the second and third
                                                           Day  reports were obtained after the treatments were done,
           Figure 2: Circumference changes from baseline by day and study   and no treatment had to be stopped secondary to pain.
           group in control area (untreated thighs)           Nevertheless, all subjects who reported “unbearable”
                                                              pain completed all treatments and follow-up procedures
           was observed in the relative change between the    as scheduled.
           treated and untreated areas at all time points, with the
           exception of the low-power group on day 14.        Evaluation of the feedback questionnaire revealed that
                                                              on day 28, in response to the item on visible change
           Representative photographs of abdominal circumference   in appearance, a favorable change was reported by
           before and after treatment are shown [Figure 3].   27.8% of the high-power group and 41.2% of the low-
                                                              power group [Table 4]. On day 56, these rates rose to
           Subject satisfaction                               61.1% and 64.7%, respectively. On day 84, 1 month
           Most subjects felt no pain or only minimal pain during   following third treatment, 68.4% of the high-power
           all treatments, 92 of 108 documented encounters    group reported a positive visible change compared to
           (85.1%). The high-power group reported a slightly   58.8% of the low-power group [Table 4]. At the same
           greater pain sensation when compared to the low-   time point, 57.9% of the high-power group reported
           power group: rates of no pain or minimal pain reported   positive comments from others, and 68.4% claimed
           by the high-power group were 79.0% after the first   they would recommend the procedure to their friends;
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