A Prospective, Open-Label Study to Evaluate Functional Changes Following Electromagnetic Muscle Stimulation of Abdominal Muscle.

Background: Electromagnetic muscle stimulation (EMMS) is an effective, well-tolerated noninvasive body contouring treatment for strengthening, toning, and firming the abdomen. Objectives: In this study, functional changes following abdominal EMMS treatment wereevaluated. Methods: In this prospective, open-label study, adults received 8 abdominal EMMS treatments (2 treatments on nonconsecutive days/week over 4 weeks). Follow-ups occurred 1 month (primary endpoint), 2, and 3 months postfinal treatment. Effectiveness endpoints included improvements from baseline on Body Satisfaction Questionnaire (BSQ; primary endpoint), core strength (timed plank test), abdominal endurance (curl-up test), and Subject Experience Questionnaire (SEQ). Safety was evaluated throughout. Results: Sixteen participants (68.8% female) were enrolled, with a mean age of 39.3 years and a mean BMI of 24.4 kg/m2; 14 participants completed the study per protocol. Mean BSQ scores were significantly improved from baseline (27.9) to the 1-month follow-up (36.6; P < .05). Core strength and abdominal endurance were significantly greater at the 1-, 2-, and 3-month posttreatment time points than at baseline (P < .05). Frequently cited reasons for seeking EMMS treatment included a desire to feel stronger (100%; n = 14/14) and to improve athletic performance (100%; n = 14/14). SEQ responses 3 months posttreatment showed that most participants reported feeling stronger (92.9%) and motivated to receive additional EMMS treatments (100%) and work out to maintain treatment results (100%). The majority of participants (>78%) reported being "satisfied" or "very satisfied" with abdominal treatment 1 month posttreatment. One device- and/or procedure-related adverse event of menstrual cycle irregularity was reported in 1 participant and was mild in severity. Conclusions: EMMS treatment of the abdomen is associated with functional strength improvements and high patient satisfaction.

Feasibility Study of Electromagnetic Muscle Stimulation and Cryolipolysis for Abdominal Contouring.

BACKGROUND: In addition to reducing subcutaneous fat for body contouring, some patients are interested in toning the underlying muscle layer. OBJECTIVE: This feasibility study evaluated the safety and efficacy of electromagnetic muscle stimulation (EMMS) alone, cryolipolysis alone, and cryolipolysis with EMMS for noninvasive contouring of abdomen. METHODS: Abdomens of 50 subjects were treated in a study with 3 cohorts: EMMS alone, Cryolipolysis alone, and Cryolipolysis + EMMS in combination. Electromagnetic muscle stimulation treatments were delivered in 4 sessions over 2 weeks. Cryolipolysis treatments were delivered in one session. Combination treatments consisted of one cryolipolysis and 4 EMMS visits. Efficacy was assessed by independent physician Global Aesthetic Improvement Scale (GAIS), circumferential measurement, Subject GAIS (SGAIS), and Body Satisfaction Questionnaire (BSQ). RESULTS: Safety was demonstrated for all study cohorts with no device- or procedure-related adverse events. Independent photo review showed greatest mean GAIS score for the Cryolipolysis + EMMS cohort followed by Cryolipolysis only, then EMMS only cohort. BSQ showed greatest average score increase for Cryolipolysis + EMMS cohort followed by Cryolipolysis only cohort, then EMMS only cohort. Mean circumferential reduction measurements were greatest for Cryolipolysis + EMMS cohort followed by Cryolipolysis only, and then EMMS only cohort. The mean SGAIS improvement score was equal for the Cryolipolysis only and Cryolipolysis + EMMS cohorts, followed by the EMMS only cohort. CONCLUSION: A multimodal approach using cryolipolysis and EMMS was safe and demonstrated enhanced body contouring efficacy for this feasibility study.

Multiple same day cryolipolysis treatments for the reduction of subcutaneous fat are safe and do not affect serum lipid levels or liver function tests.

OBJECTIVE: Cryolipolysis is a safe and effective non-surgical procedure for reducing subcutaneous fat. It spares adjacent structures, is associated with few adverse events, and is well-tolerated by patients. Previous studies involving one or two simultaneous treatment sites have shown no effect on serum lipid levels or liver tests. The purpose of this study was to determine whether multiple same day treatments (abdomen plus both flanks) result in changes in these blood tests, and is safe. STUDY DESIGN: Thirty-five adult males and females underwent same-day cryolipolysis (CoolSculpting System, ZELTIQ Aesthetics) of the lower abdomen and flanks for reduction of subcutaneous fat. Serum lipids and liver tests were measured prior to treatment and at 1, 4, and 12 weeks post-treatment. Expected treatment side-effects were assessed immediately post-treatment and at the 12-week follow-up visit. Adverse events were also monitored. METHODS: Treatment consisted of one cycle to the lower abdomen using a large vacuum applicator and simultaneous treatment of both flanks, one cycle each, with medium vacuum applicators .Time between the abdomen and flanks procedures was not to exceed 30 minutes. RESULTS: The procedures were well-tolerated by patients; expected treatment effects were in general mild or moderate, and resolved without intervention. There were no clinically meaningful changes from baseline to any subsequent time point in any serum lipid test. This was also true for all liver tests. There were no treatment-related adverse events. CONCLUSION: Multiple cycle, same day cryolipolysis treatment of the lower abdomen and both flanks is well-tolerated and safe. It does not lead to changes in serum lipids or liver tests at any of the measured time points following the procedure. Lasers Surg. Med. 49:640-644, 2017. © 2017 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals Inc.

Cryolipolysis conformable-surface applicator for nonsurgical fat reduction in lateral thighs.

BACKGROUND: Vacuum applicators have been effective for cryolipolysis of the abdomen, flanks, inner thighs, back, chest, and arms. However, the lateral thighs have not been easily treated because fat from this area cannot be easily drawn into a vacuum cup. OBJECTIVES: The authors investigated the safety and efficacy of a prototype applicator for treatment of "nonpinchable" fat in the lateral thighs. METHODS: In this prospective, nonrandomized, interventional cohort, multicenter study, a 120-minute unilateral treatment with a prototype conformable-surface applicator was performed on 1 lateral thigh of 40 patients, with the contralateral thigh serving as the control. During follow-up visits at 2 and 4 months, fat reduction was assessed by ultrasound imaging and clinical photography, and patient satisfaction surveys were completed. RESULTS: Ultrasound data indicated a 2.6-mm mean normalized reduction in fat thickness-a statistically significant reduction vs the untreated control thigh (P = 7.8E-8). According to patient survey responses, 89% of patients would recommend the procedure to a friend; 86% were satisfied with cryolipolysis for the lateral thighs; 86% noticed visible fat reduction; and 97% were likely to undergo a second treatment. A panel of 3 independent blinded physicians correctly identified baseline and posttreatment clinical photographs in 87% of cases. There were no serious adverse events or unanticipated adverse device effects. CONCLUSIONS: The cryolipolysis conformable-surface applicator was safe and efficacious for treatment of lateral thigh fat. Clinical photographs and ultrasound results showed significant reduction in fat thickness, and noticeable reduction in undesirable "saddlebag" bulges. LEVEL OF EVIDENCE 3: Therapeutic.

Non-invasive cryolipolysis for subcutaneous fat reduction does not affect serum lipid levels or liver function tests.

BACKGROUND AND OBJECTIVE: Cryolipolysis provides a method of non-invasive fat reduction that significantly reduces subcutaneous fat without injury to adjacent tissues. Preliminary animal and human data have suggested that cryolipolysis has no effect on serum lipid profiles or liver tests. This study was intended to more fully document any effect of this procedure on lipid and liver-related blood tests. STUDY DESIGN/MATERIALS AND METHODS: Forty subjects with fat bulges on their flanks ("love handles") were treated bilaterally with a non-invasive device (Zeltiq Aesthetics, Pleasanton, CA) that precisely cools tissue to achieve a reduction in the fat layer. Serum lipid levels and liver tests were measured prior to treatment, and at 1 day and 1, 4, 8, and 12 weeks post-treatment. RESULTS: No meaningful changes in mean values were observed for any blood lipid level or liver test at any point over the 12-week follow-up period. CONCLUSION: Cryolipolysis, when used for reduction of subcutaneous flank fat, is not associated with changes in serum lipids or liver test results.