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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Full Treatment Arm (Laser + EMS + RF/PEMF) | Active Comparator | 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). |
|
| Arm B: EMS/RF Arm (EMS + RF/PEMF) | Active Comparator | 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: EMS Arm (EMS only) | Active Comparator | Arm C: Subjects will receive weekly electrical muscle stimulation treatments at days 0, 7, 14, 21, 28 and 35 (±2 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMS | Device | Abdominal muscle stimulation using EMS |
|
| 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) |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Abdominal Ultrasound images (optional) | Abdominal fat and muscle thickness (millimeters) changes from baseline to Follow-up 1 & 2 post last treatment as assessed using abdominal US images, compared to baseline. | Follow-up 1: 84 days (Arm A & B); 63 days (Arm C). Follow-up 2: 140 days (Arms A & B); 119 days (Arm C) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinical Research - General Medicine | San Diego | California | 92121 | United States | ||
| Schweiger Dermatology Group |
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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)
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Blinded, independent photo review comparing the pre-treatment and post-treatment Follow-up 2 photographs by a physician board-certified in dermatology to evaluate contour improvement per the Global Aesthetic Improvement Scale (GAIS).
Blinded Investigator review comparing the pre-treatment photographs and post-treatment Follow-up 1 & 2 live assessment by the Primary Investigator to evaluate contour improvement per the Global Aesthetic Improvement Scale (PI-GAIS).
| 1064 nm diode laser | Device | Adipose tissue heating using 1064 nm diode laser |
|
| RF/PEMF | Device | Collagen re-modelling and reduction in subcutaneous fat using RF/PEMF |
|
| 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) |
| Change in Abdominal Magnetic Resonance Imaging (MRI) (optional) |
Abdominal fat and muscle thickness (millimeters) changes from baseline to Follow-up 2 post last treatment as assessed using MRI, compared to baseline. |
| Follow-up 2: 140 days (Arms A & B); 119 days (Arm C) |
| Hackensack |
| New Jersey |
| 07601 |
| United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| ID | Term |
|---|---|
| D009122 | Muscle Hypertonia |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054023 | Lasers, Semiconductor |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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