Safety and Tolerability of a Focused Ultrasound Device for Treatment of Adipose Tissue in Subjects Undergoing Abdominoplasty: A Placebo-Control Pilot Study

Shalom, Avshalom; Wiser, Itay; Brawer, Solli; Azhari, Haim

doi:10.1111/dsu.12123

Cited by 24 publications

(10 citation statements)

References 11 publications

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“…However, despite many individual – often only anecdotal – user reports, only a minority of methods is proven according to the evidence-based medicine standards. Such evidence is available for efficacy of chemical lipolysis, based on injection of phosphatidylcholine and deoxycholic acid 9 , and for selected energy-based technologies using focused ultrasound 10 , cryolipolysis 11 and/or thermal/radiofrequency for lipolysis 12 . Despite the broad use in the practice, clinical safety data of these aesthetic procedures are scarce, with only a few publications available 13 .…”

Section: Introductionmentioning

confidence: 99%

Non-contact radiofrequency-induced reduction of subcutaneous abdominal fat correlates with initial cardiovascular autonomic balance and fat tissue hormones: safety analysis

et al. 2015

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Background and objective: The non-invasive reduction of subcutaneous abdominal fat became popular in the last decade. Radiofrequency (RF), non-contact, selective-field device Vanquish® has been developed to selectively induce deep fat tissue heating to reduce waist circumference. Our analysis evaluates immediate and sustained effects of this treatment on cardiovascular autonomic function and on selected metabolic parameters. Study design/ patients and methods: A retrospective proof-of-concept analysis of RF treatment effects was conducted in 20 individuals with metabolic syndrome, to reduce the subcutaneous abdominal fat. Four 30-minutes treatment sessions (manufacturer´s standard protocol) were performed in 1-week intervals. Vital signs, ECG, lab screening, body composition, subcutaneous fat thickness and spectral analysis of heart rate variability (HRV) have been examined before, after the 1 st and 4 th treatment, and at follow-up visits 1 month and 3 months after the treatment. Results: The RF treatment led to a significant reduction of abdominal circumference after the 4 th session (p<0.001), and during follow-up after 1 and 3 months (p<0.001 and p<0.02, resp.). There was a significant correlation (r=-0.58, p=0.007) between reduction of abdominal circumference and initial very-low frequency (VLF) spectral power at 1 month follow-up. A significant increase of cumulative spectral power in low frequency (p=0.02) and reduction in high frequency (p=0.05) band have been observed immediately (20 +14 minutes) after the treatment. On the contrary, no sustained impact on autonomic balance has been recorded 39 +18 days after the treatment. A significant correlation between the initial adiponectin values and immediate autonomic response to one treatment was observed in VLF and total spectral bands (r>0.59, p<0.04). Conclusions: Our analysis shows that the selective-field RF treatment is safe and efficient for reduction of subcutaneous abdominal fat. While the treatment increases the immediate sympathetic response of the body to deep tissue heating, no sustained change in autonomic function could be recorded at 1 month follow-up. The observed correlation between initial VLF spectral power and waist circumference reduction at follow-up, as well as the association of initial adiponectin values and immediate autonomic response to the treatment might be instrumental for decisions on body contouring strategies.

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Section: Introductionmentioning

confidence: 99%

Non-contact radiofrequency-induced reduction of subcutaneous abdominal fat correlates with initial cardiovascular autonomic balance and fat tissue hormones: safety analysis

et al. 2015

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“…In one application, ultrasound has been used alongside laser facial resurfacing to enhance transdermal cosmeceutical delivery [114]. Another cosmetic application that has been tested in humans is body sculpting, where high intensity FUS is used to ablate adipose tissue that is then later resorbed [115]. A randomized, sham-controlled body sculpting study found no difference in adverse events in the treated and sham groups at 24 week follow-up, suggesting that the treatment is safe [116].…”

Section: Cosmeticmentioning

confidence: 99%

Emerging non-cancer applications of therapeutic ultrasound

O’Reilly

Hynynen

2015

International Journal of Hyperthermia

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Ultrasound therapy has been investigated for over half a century. Ultrasound can act on tissue through a variety of mechanisms, including thermal, shockwave and cavitation mechanisms, and through these can elicit different responses. Ultrasound therapy can provide a non-invasive or minimally invasive treatment option, and ultrasound technology has advanced to the point where devices can be developed to investigate a wide range of applications. This review focuses on non-cancer, clinical applications of therapeutic ultrasound, with an emphasis on treatments that have recently reached clinical investigations, and preclinical research programs that have great potential to impact patient care.

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“…The combination of a mechanical effect, that disrupts the cell membranes immediately, and a thermal mechanism, that destroys adipocytes at temperatures above 58°C, causes coagulative necrosis within a small targeted area while the surrounding tissue remains mostly unaffected 2. Studies have shown evidence of fat necrosis3 and an average reduction in waist circumference of more than 2 cm 12 weeks after a single treatment 4…”

Section: Body Contouring Techniquesmentioning

confidence: 99%

Cryolipolysis for noninvasive body contouring: clinical efficacy and patient satisfaction

Krueger¹,

Sophia²,

Luebberding³

et al. 2014

CCID

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In recent years, a number of modalities have become available for the noninvasive reduction of adipose tissue, including cryolipolysis, radiofrequency, low-level laser, and high-intensity focused ultrasound. Each technology employs a different mechanism of action to cause apoptosis or necrosis of the targeted adipocytes. Among these technologies, cryolipolysis has not only been commercially available for the longest time, but has also been best researched including in vitro and animal models and randomized controlled clinical trials in humans. The principle behind cryolipolysis exploits the premise that adipocytes are more susceptible to cooling than other skin cells. The precise application of cold temperatures triggers apoptosis of the adipocytes, which invokes an inflammatory response and leads to slow digestion by surrounding macrophages. In clinical studies, cryolipolysis was shown to reduce subcutaneous fat at the treatment site by up to 25% after one treatment. Improvements were seen in 86% of treated subjects. At 73%, the patient satisfaction rate is higher than with other technologies used for noninvasive lipolysis. Cryolipolysis has been proven to be a very safe method for body contouring, and is accomplished with only minimal discomfort. Expected side effects are temporary erythema, bruising, and transient numbness that usually resolve within 14 days after treatment. With a prevalence of 0.1%, the most common complaint is late-onset pain, occurring 2 weeks post-procedure, which resolves without intervention. Although no procedure has been accepted as the gold standard for noninvasive body contouring as yet, cryolipolysis is considered to be both safe and efficient with a high patient satisfaction rate.

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Safety and Tolerability of a Focused Ultrasound Device for Treatment of Adipose Tissue in Subjects Undergoing Abdominoplasty: A Placebo-Control Pilot Study

Abstract: High-intensity focused ultrasound treatment was well tolerated and safe. Focal damage to target tissue was documented, with adjacent tissues remaining intact.

Cited by 24 publications

References 11 publications

Non-contact radiofrequency-induced reduction of subcutaneous abdominal fat correlates with initial cardiovascular autonomic balance and fat tissue hormones: safety analysis

Non-contact radiofrequency-induced reduction of subcutaneous abdominal fat correlates with initial cardiovascular autonomic balance and fat tissue hormones: safety analysis

Emerging non-cancer applications of therapeutic ultrasound

Cryolipolysis for noninvasive body contouring: clinical efficacy and patient satisfaction

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