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An Innovative Non-Surgical System for Body Contouring, Cellulite Reduction, and Improved Health Gregory Chernoff, M.D., F.R.C.S.(C) Chernoff and Associates Cosmetic Surgery, Laser, and Wellness Centers C L I N I C A L R E S E A R C H BACKGROUND There have been many non-surgical body- contouring systems introduced over the past ten years. These systems have attempted to implement lasers, radio frequency, infrared energy, ultrasound, and cryotherapy, to disrupt the adipose cell membrane in hopes of causing circumferential reduction. Results have varied from poor to fair, with good physiological explanation. Once the fat cells have been disrupted, the assumption was made that the patient’s body would excrete the resultant triglycerides and fatty acids. Little evidence exists that this was the case. Chernoff Cosmetic Surgery, Laser, and Wellness Center Contact: [email protected] Indianapolis, IN: 317.573.8899 Santa Rosa, CA: 707.544.3232 ©2014 All Rights Reserved. OBJECTIVE A novel bimodal instrument is studied. First, a hand held ultrasound transducer generating 1 Mhz is utilized to emulsify fat in a specific treatment area. Immediately afterwards, the application of muscle biostimulation is performed, targeting the same specific treatment area. It is hypothesized that the deep muscle stimulation creates a scenario of energy consumption, allowing the released triglycerides to be consumed by the body. The aim of this study is to examine BMI, circumferential reduction, cellulite reduction, muscle toning, skin tightening, longevity of results, and hematological tests before and after treatments are completed. ABSTRACT Non-surgical body sculpting systems have attempted to implement lasers, radio frequency, infrared energy, ultrasound, and cryotherapy, to disrupt the adipose cell membrane in hopes of causing circumferential reduction. Our center studied a novel bimodal instrument to test the safety and efficacy for patient use. We examined both the physical and psychological changes in each patient.

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Page 1: An Innovative Non-Surgical System for Body Contouring ...futurafit.com/wp-content/uploads/2016/01/FuturaPro... · Cellulite Reduction, and Improved Health Gregory Chernoff, M.D.,

An Innovative Non-Surgical System for Body Contouring, Cellulite Reduction, and Improved Health

Gregory Chernoff, M.D., F.R.C.S.(C) Chernoff and Associates Cosmetic Surgery, Laser, and Wellness Centers

C L I N I C A L R E S E A R C H

BACKGROUND There have been many non-surgical body-contouring systems introduced over the past ten years. These systems have attempted to implement lasers, radio frequency, infrared energy, ultrasound, and cryotherapy, to disrupt the adipose cell membrane in hopes of causing circumferential reduction.

Results have varied from poor to fair, with good physiological explanation. Once the fat cells have been disrupted, the assumption was made that the patient’s body would excrete the resultant triglycerides and fatty acids. Little evidence exists that this was the case.

Chernoff Cosmetic Surgery, Laser, and Wellness Center Contact: [email protected] Indianapolis, IN: 317.573.8899 Santa Rosa, CA: 707.544.3232 ©2014 All Rights Reserved.

OBJECTIVE A novel bimodal instrument is studied. First, a hand held ultrasound transducer generating 1 Mhz is utilized to emulsify fat in a specific treatment area. Immediately afterwards, the application of muscle biostimulation is performed, targeting the same specific treatment area.

It is hypothesized that the deep muscle stimulation creates a scenario of energy consumption, allowing the released triglycerides to be consumed by the body. The aim of this study is to examine BMI, circumferential reduction, cellulite reduction, muscle toning, skin tightening, longevity of results, and hematological tests before and after treatments are completed.

ABSTRACT Non-surgical body sculpting systems have attempted to implement lasers, radio frequency, infrared energy, ultrasound, and cryotherapy, to disrupt the adipose cell membrane in hopes of causing circumferential reduction. Our center studied a novel bimodal instrument to test the safety and efficacy for patient use. We examined both the physical and psychological changes in each patient.

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CLINICAL RESEARCH

METHODS Fifteen patients underwent a series of six treatment sessions, spaced one week apart. Each treatment consisted of thirty minutes of ultrasound therapy, followed by thirty minutes of electrical muscle biostimulation.

Pre-treatment measurements, weight and photographs were taken. Pre-treatment hematology examined Triglycerides, Cholesterol, LDL, HDL, Glucose, and C-Reactive Protein. The same blood draw was performed after the sixth session. Patients were re-examined six months and one year after treatment.

Greg Chernoff, M.D., F.R.C.S.(C) Chernoff Cosmetic Surgery, Laser, and Wellness Center ©2014 All Rights Reserved.

RESULTS All enrolled patients experienced circumferential reduction in the areas treated. Patients with higher BMI’s at initiation saw proportionately greater losses than those with smaller stature. Patients treated for unwanted cellulite, muscle toning and skin tightening, expressed “high satisfaction” on linear analog scores. Of particular interest were the associated improvement in health parameters. All patients had a reduction in Cholesterol. Triglycerides and Glucose levels. LDL decreased, while HDL increased. Longevity at six months to one year is statistically valid.

CONCLUSION The FuturoPro offers a unique addition to the armamentarium of non-surgical body sculpting therapies.

INTRODUCTION: The medical aesthetic industry has seen a significant growth in minimally or non-invasive energy based body shaping systems. While surgical options remain the gold standard in most cases, the latest less invasive technologies and products have shown progressive improvement over earlier generation systems. Herein lies the dilemma. Human nature has shown that patients prefer a “quick fix”, preferably non-surgical, largely due to the popular negative misconceptions surrounding the word “surgery”. If they are then told that the non-surgical options provide a viable alternative, the resultant expectations are often those of the results that surgical options, (liposuction or abdominoplasty) can yield. This is simply not the case. However, when positioned properly, giving patient’s realistic expectations, high levels of satisfaction can be achieved.

The non-surgical systems attract patients who may be fearful of surgery, cannot afford surgery, or those for whom medical conditions, yield surgery as a non-option. To date, several technologies have been attempted. These have employed methods to disrupt the integrity of the fat cell either reducing the size of the fat cell or interrupting the cell wall with resultant leakage of fatty acids and triglycerides. The most popular technologies consist of ultrasound, radiofrequency(RF), laser and cold energy, radial shock waves and magnetic pulse therapy. All of these systems have a physiological flaw. While they all, to varying degrees, cause damage to the fat cell, they all rely on the patients’ body to remove the byproducts, a hypothesis that is flawed, if nothing changes physiologically for the patient, ie: diet, exercise. This is the flaw with these systems.

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CLINICAL RESEARCH

Greg Chernoff, M.D., F.R.C.S.(C) Chernoff Cosmetic Surgery, Laser, and Wellness Center ©2014 All Rights Reserved.

The Futura Pro addresses excess fat, cellulite, skin elasticity, and muscle tone, from a physiological perspective. The deep ultrasound of 1 MHz frequency creates acoustic and thermal damage to the fat cell wall. This yields a release of fatty acids and triglycerides. The muscle stimulation creates a negative energy scenario for which the exhausted muscles seek fuel…namely the released fatty acids and triglycerides. The net effect is reduction of fat, increased muscle tone, and improvement in the appearance of cellulite. It is the bimodal function of the Futura Pro which theoretically sets it apart from competitors. The ability to stimulate muscle contraction to exhaustion enables the consumption of the released fat byproducts which does not happen with any of the existing systems available on the market.

PATIENTS AND METHODS: From January, 2014 to March 2014, 15 consecutive patients (13 female, 2 male), were treated with the Futura Pro System. Ages ranged from 24 to 58. BMI ranged from 21.5 to 34.2 with a mean of 27.5. Patients were treated weekly for six weeks. Photographs were taken before and after each treatment. Patients were weighed and measured before and after each treatment. Measurements were standardized and described as Abdomen High, Abdomen Navel, and Abdomen Low.

Each treatment consisted of thirty minutes of ultrasound, followed by thirty minutes of muscle stimulation. The diathermic ultrasound signal is delivered via an acoustic coupling gel. The ultrasound applicator has all the necessary controls (on/off amplitude) in the handset and derives only a time controlled power source from the main control unit. The muscle stimulation component consists of a main control unit which powers and controls a separate stimulator that repetitively contracts skeletal muscles by applying transcutaneous electrical pulses to areas of the body that require therapy for the indicated conditions.

These pulses for muscle stimulation are applied via self-adhesive electrodes applied on the skin. Set programs with predetermined parameters are selected by the operator. On screen instructions guide the user, displaying numbered programs, indication of intensity levels, adjustments, and treatment use. The output leads have indicator LED’s identifying each output as the electrodes are positioned and the intensity is adjusted.

Each patient consented to the following hematological tests. Serum Triglycerides, Cholesterol, HDL, LDL, Glucose, Homocysteine, and C-Reactive Protein were drawn Pre Treatment, Post Ultrasound, and Post Muscle Stimulation. Patients were followed for six months, and follow-up parameters examined.

RESULTS: Patient measurements are summarized in Table 1. Hematological results are summarized in Table 2. Patient photographs with individual summaries are found in Table 3.

All but one patient lost weight ranging from 1 pound to 14 pounds with a mean of 7.1 pounds. All but one patient decreased abdominal girth measurements. High abdomen losses ranged from 0.5 cm to 14 cm with a mean of 5.4 cm. Abdominal umbilical losses ranged from 0.6 cm to 14 cm with a mean of 5.4 cm. Low abdominal losses ranged from 0.9 cm to 12 cm with a mean of 5.3 cm.

Hematological results proved interesting. The majority of patients had a reduction of Triglycerides, Cholesterol, LDL, and Glucose. HDL showed little change, or increased in some patients. Homocystein and C-Reactive Protein were reflective of muscle stimulation and muscle building.

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CLINICAL RESEARCH

Greg Chernoff, M.D., F.R.C.S.(C) Chernoff Cosmetic Surgery, Laser, and Wellness Center ©2014 All Rights Reserved.

Of particular interest was the psychological profiles of the study participants. There was a direct correlation between weight reduction and circumferential reduction with the motivation, dietary modification, exercise participation, and psychological support extended to the participants.

Six month follow-up showed a correlation between maintenance of circumferential reduction and the maintenance of a diet that successfully reduces caloric intake, as well as lifestyle interventions that promote behavioral changes to support adherence to a calorie-restricted, nutrient dense diet.

The psychological support provided to the patient by loved ones also has been shown to play a significant role in the success of any program.

DISCUSSION The obesity epidemic has fostered the development of numerous non-surgical systems heralding weight loss, circumferential reduction and improvement in resultant skin quality. Human nature being what it is, fosters interest in these treatments by those afflicted for the same reasons they are obese. They want an easy solution, with little to no effort on their part to effect behavioral changes, ie. Exercise and diet; that would be conducive to better health.

The past five years have yielded the emergence of laser, RF, ultrasound, cavitation, and cryolipolysis technologies to attempt to help these patients who may not otherwise be surgical candidates for health, psychological or monetary reasons. Long-term results from the aforementioned systems are lacking in the literature. There are many papers discussing the short-comings.

Intuitively, it makes sense that if we simply damage a fat cell, causing the release of fatty byproducts, our bodies can only excrete a certain amount. Additionally, if the lifestyle of the patient in question does not change for the better relating to diet and exercise, then why will anything change?

The Futura Pro has shown to provide effective ultrasonic fat cavitation, fat breakdown and intense muscle activation, with subsequent circumferential reduction. The concurrent muscle stimulation, rendering the muscles exhausted, create the scenario of muscle seeking fuel, which has been presented to the muscle by the ultrasonic cavitation of fat yielding fatty acids and glycerol for energy attainment by the hungry muscles. The net effect is loss of fat, and increase in muscle tone.

The long-term maintenance of the results… or lack thereof, is directly proportional to the motivation possessed by the patient relating to the maintenance of a nutrient rich diet and regular exercise program. These parameters have a greater chance of success IF the patient has a strong psychological support system to offer accountability.

CONCLUSION: The Futura Pro dual modality therapeutic fat reduction system offers a viable and efficacious addition to the armamentarium of the physician involved in the treatment of those patients afflicted with obesity or those seeking to reduce selected fatty areas, increase muscle tone, or improve their health relating to those hematological markers lending to morbidity.

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CLINICAL RESEARCH

Greg Chernoff, M.D., F.R.C.S.(C) Chernoff Cosmetic Surgery, Laser, and Wellness Center ©2014 All Rights Reserved.

Table 1. Hematological Results

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CLINICAL RESEARCH

Greg Chernoff, M.D., F.R.C.S.(C) Chernoff Cosmetic Surgery, Laser, and Wellness Center ©2014 All Rights Reserved.

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CLINICAL RESEARCH

Greg Chernoff, M.D., F.R.C.S.(C) Chernoff Cosmetic Surgery, Laser, and Wellness Center ©2014 All Rights Reserved.

Table 2 - Patient Measurements

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CLINICAL RESEARCH

Greg Chernoff, M.D., F.R.C.S.(C) Chernoff Cosmetic Surgery, Laser, and Wellness Center ©2014 All Rights Reserved.

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CLINICAL RESEARCH

Greg Chernoff, M.D., F.R.C.S.(C) Chernoff Cosmetic Surgery, Laser, and Wellness Center ©2014 All Rights Reserved.

Table 3 - Patient Photographs & Measurements

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CLINICAL RESEARCH

Greg Chernoff, M.D., F.R.C.S.(C) Chernoff Cosmetic Surgery, Laser, and Wellness Center ©2014 All Rights Reserved.

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CLINICAL RESEARCH

Greg Chernoff, M.D., F.R.C.S.(C) Chernoff Cosmetic Surgery, Laser, and Wellness Center ©2014 All Rights Reserved.

Page 12: An Innovative Non-Surgical System for Body Contouring ...futurafit.com/wp-content/uploads/2016/01/FuturaPro... · Cellulite Reduction, and Improved Health Gregory Chernoff, M.D.,

CLINICAL RESEARCH

Greg Chernoff, M.D., F.R.C.S.(C) Chernoff Cosmetic Surgery, Laser, and Wellness Center ©2014 All Rights Reserved.

Page 13: An Innovative Non-Surgical System for Body Contouring ...futurafit.com/wp-content/uploads/2016/01/FuturaPro... · Cellulite Reduction, and Improved Health Gregory Chernoff, M.D.,

CLINICAL RESEARCH

Greg Chernoff, M.D., F.R.C.S.(C) Chernoff Cosmetic Surgery, Laser, and Wellness Center ©2014 All Rights Reserved.