Electrical Muscle Stimulation With 1064 nm Diode Laser and RF/PEMF for Non-invasive Body Contouring and Fat Reduction.

Study Overview
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Brief Summary
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Multi-center, three-arm, randomized, evaluator-blinded study of electrical muscle stimulation (EMS) and/or 1064 nm diode laser, pulsed electromagnetic field (PEMF) and vacuum assisted radio frequency (RF) using the Venus Bliss Max for fat reduction, body contouring and aesthetic improvement.

Detailed Description
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The study will enroll up to 60 male and female subjects, ≥ 18 years of age, requesting non-invasive electrical muscle stimulation (EMS) and/or lipolysis of the abdomen and flanks. Subjects will be randomized to one of three arms as per randomization scheme. This study will have 3 Arms at a ratio of 2:1:1 (A:B:C): Arm A: Full Treatment Arm (Laser + EMS + RF/PEMF) Arm B: EMS/RF Arm (EMS + RF/PEMF) Arm C: EMS Arm (EMS only) Arm A: Three (3) diode laser treatments treatments at days 0, 28 and 56 (±2 days). Subjects will also receive bi-weekly electrical muscle stimulation and pulsed electromagnetic fields (PEMF)/vacuum assisted radio frequency (RF) treatments at days 0, 14, 28, 42 and 56 (±2 days). Arm B: Subjects will receive bi-weekly electrical muscle stimulation and pulsed electromagnetic fields/vacuum assisted radio frequency treatments at days 0, 14, 28, 42 and 56 (±2 days). Arm C: Subjects will receive weekly electrical muscle stimulation treatments at days 0, 7, 14, 21, 28 and 35 (±2 days). Subjects in Arms A and B will be followed at 84 and 140 days (±7 days) after their last treatment. Subjects in Arm C will be followed at 63 and 119 days (±7 days) after their last treatment.

Official Title
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Safety and Efficacy of Electrical Muscle Stimulation Combined With 1064 nm Diode Laser, Pulsed Electromagnetic Field (PEMF) and Vacuum Assisted Radio Frequency (RF) for Non-invasive Body Contouring and Fat Reduction.

Conditions
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Fat Reduction, Muscle Tone Increased

Intervention / Treatment
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* Device: EMS
* Device: 1064 nm diode laser
* Device: RF/PEMF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects > 18 years of age and ≤65 years of age. Subject agrees to refrain from any new abdominal training exercises during the course of the study. BMI ≤ 30 kg/m2 as determined at screening. Subject has read and signed a written informed consent form. Exclusion Criteria: Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months, including presence of post-partum diastasis. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months. History of immunosuppression/immune deficiency disorders (including AIDS and HIV infection) or use of immunosuppressive medications last 6 months prior to and during the course of the study. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding. Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted), anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks of treatment or a history of bleeding disorders. History of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions. Having a permanent implant in the treatment area such as metal plates or an injected chemical substance such as silicone or parenteral gold therapy (gold sodium thiomalate), or drug delivery system that would prevent treatment at the treatment site. Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or history of photosensitivity disorder. Suffering from significant skin conditions in the treatment area or inflammatory skin conditions including but not limited to open lacerations, abrasions, herpes sores, cold sores, active infections. Tattoos in the treatment area Numbness, tingling or other altered sensation in the treatment area. Known sensitivity or allergy to isopropyl alcohol and propylene glycol, hydrogel or latex or any substance used during treatments by the clinic (if applicable). Unable or unwilling to comply with the study requirements. Enrolled in a clinical study of any other investigational drug or device. Any other condition or laboratory value that would, in the professional opinion of the Investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 Arms at a ratio of 2:1:1 (A:B:C): Arm A: Full Treatment Arm (Laser + EMS + RF/PEMF) Arm B: EMS/RF Arm (EMS + RF/PEMF) Arm C: EMS Arm (EMS only)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A: Full Treatment Arm (Laser + EMS + RF/PEMF)<br>Arm A: Three (3) diode laser treatments treatments at days 0, 28 and 56 (±2 days). Subjects will also receive bi-weekly electrical muscle stimulation and pulsed electromagnetic fields/vacuum assisted radio frequency treatments at days 0, 14, 28, 42 and 56 (±2 days). | Device: EMS<br>* Abdominal muscle stimulation using EMS<br>Device: 1064 nm diode laser<br>* Adipose tissue heating using 1064 nm diode laser<br>Device: RF/PEMF<br>* Collagen re-modelling and reduction in subcutaneous fat using RF/PEMF<br>|
| Active Comparator: Arm B: EMS/RF Arm (EMS + RF/PEMF)<br>Arm B: Subjects will receive bi-weekly electrical muscle stimulation and pulsed electromagnetic fields/vacuum assisted radio frequency treatments at days 0, 14, 28, 42 and 56 (±2 days). | Device: EMS<br>* Abdominal muscle stimulation using EMS<br>Device: RF/PEMF<br>* Collagen re-modelling and reduction in subcutaneous fat using RF/PEMF<br>|
| Active Comparator: Arm C: EMS Arm (EMS only)<br>Arm C: Subjects will receive weekly electrical muscle stimulation treatments at days 0, 7, 14, 21, 28 and 35 (±2 days). | Device: EMS<br>* Abdominal muscle stimulation using EMS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blinded, independent photo review comparing the pre-treatment and post-treatment photographs. | Physician board-certified dermatologist to evaluate contour improvement per the Global Aesthetic Improvement Scale (GAIS), with scores in order of 'most improved' to 'worse': Most improved (score of 5); Much improved (score of 4); Improved (score of 3); No change (score of 2); Worse (score of 1). | 140 days (Arms A & B); 119 days (Arm C) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blinded Investigator review comparing the pre-treatment photographs and post-treatment Follow-up live assessment. | Primary Investigator to evaluate live contour improvement compared to pre-treatment photographs per the Global Aesthetic Improvement Scale (GAIS), with scores in order of 'most improved' to 'worse': Most improved (score of 5); Much improved (score of 4); Improved (score of 3); No change (score of 2); Worse (score of 1). | Follow-up 1: 84 days (Arm A & B); 63 days (Arm C). Follow-up 2: 140 days (Arms A & B); 119 days (Arm C) | 
| Change in the subject Body Satisfaction Questionnaire (BSQ) | Subject self evaluation of the BSQ post treatment compared to Baseline with a possible score of: 5 (Very Satisfied); 4 (Satisfied); 3 (Neither Satisfied or Dissatisfied); 2 (Dissatisfied); and 1 (Very Dissatisfied). | Follow-up 1: 84 days (Arm A & B); 63 days (Arm C). Follow-up 2: 140 days (Arms A & B); 119 days (Arm C) | 
| Change in Anthropometric measurements: Abdominal Circumference | Pre- and post-treatment circumference (centimeters) changes made at Treatments 1 & 3 (Arm A & B) and Treatments 1 & 5 (Arm C). Follow-up visit circumference (centimeters) made at 1 and 3 months post treatment compared to baseline (All Arms). | Treatment 1 and 3; Day 0 and Day 28 (Arm A and B). Treatment 1 and 5; Day 0 and Day 28 (Arm C). Follow-up 1: 84 days (Arm A & B); 63 days (Arm C). Follow-up 2: 140 days (Arms A & B); 119 days (Arm C) | 
| Change in Anthropometric measurements: Abdominal Skinfold Thickness | Pre- and post-treatment abdominal skinfold thickness (millimeters) changes made at Treatment 1. Follow-up visit abdominal skinfold thickness (millimeters) changes made at one and three months post-treatment compared to baseline (All Arms). | Treatment 1; Day 0 (All Arms). Follow-up 1: 84 days (Arm A & B); 63 days (Arm C). Follow-up 2: 140 days (Arms A & B); 119 days (Arm C) | 
| Change in Anthropometric measurements: Weight | Pre- and post-treatment weight measurement (kg/lbs) changes made at Treatment 1. Follow-up visit weight measurement (kg/lbs) changes made at one and three months post-treatment compared to baseline (All Arms). | Treatment 1; Day 0 (All Arms). Follow-up 1: 84 days (Arm A & B); 63 days (Arm C). Follow-up 2: 140 days (Arms A & B); 119 days (Arm C) |