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

Primary Purpose

Fat Reduction, Muscle Tone Increased

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EMS
1064 nm diode laser
RF/PEMF
Sponsored by
Venus Concept
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fat Reduction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male and female subjects > 18 years of age and ≤65 years of age.
  2. Subject agrees to refrain from any new abdominal training exercises during the course of the study.
  3. BMI ≤ 30 kg/m2 as determined at screening.
  4. Subject has read and signed a written informed consent form.

Exclusion Criteria:

  1. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months, including presence of post-partum diastasis.
  2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in the treatment area in the past 12 months.
  3. 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.
  4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy or excessive bleeding.
  5. 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.
  6. History of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
  7. 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.
  8. Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or history of photosensitivity disorder.
  9. 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.
  10. Tattoos in the treatment area
  11. Numbness, tingling or other altered sensation in the treatment area.
  12. Known sensitivity or allergy to isopropyl alcohol and propylene glycol, hydrogel or latex or any substance used during treatments by the clinic (if applicable).
  13. Unable or unwilling to comply with the study requirements.
  14. Enrolled in a clinical study of any other investigational drug or device.
  15. 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.

Sites / Locations

  • Scripps Clinical Research - General MedicineRecruiting
  • Schweiger Dermatology Group
  • Tennessee Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Arm A: Full Treatment Arm (Laser + EMS + RF/PEMF)

Arm B: EMS/RF Arm (EMS + RF/PEMF)

Arm C: EMS Arm (EMS only)

Arm Description

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: 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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
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).
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).

Full Information

First Posted
February 3, 2022
Last Updated
May 31, 2023
Sponsor
Venus Concept
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1. Study Identification

Unique Protocol Identification Number
NCT05256771
Brief Title
Electrical Muscle Stimulation With 1064 nm Diode Laser and RF/PEMF for Non-invasive Body Contouring and Fat Reduction.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venus Concept

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fat Reduction, Muscle Tone Increased

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Full Treatment Arm (Laser + EMS + RF/PEMF)
Arm Type
Active Comparator
Arm Description
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 Title
Arm B: EMS/RF Arm (EMS + RF/PEMF)
Arm Type
Active Comparator
Arm Description
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 Title
Arm C: EMS Arm (EMS only)
Arm Type
Active Comparator
Arm Description
Arm C: Subjects will receive weekly electrical muscle stimulation treatments at days 0, 7, 14, 21, 28 and 35 (±2 days).
Intervention Type
Device
Intervention Name(s)
EMS
Intervention Description
Abdominal muscle stimulation using EMS
Intervention Type
Device
Intervention Name(s)
1064 nm diode laser
Intervention Description
Adipose tissue heating using 1064 nm diode laser
Intervention Type
Device
Intervention Name(s)
RF/PEMF
Intervention Description
Collagen re-modelling and reduction in subcutaneous fat using RF/PEMF
Primary Outcome Measure Information:
Title
Blinded, independent photo review comparing the pre-treatment and post-treatment photographs.
Description
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).
Time Frame
140 days (Arms A & B); 119 days (Arm C)
Secondary Outcome Measure Information:
Title
Blinded Investigator review comparing the pre-treatment photographs and post-treatment Follow-up live assessment.
Description
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).
Time Frame
Follow-up 1: 84 days (Arm A & B); 63 days (Arm C). Follow-up 2: 140 days (Arms A & B); 119 days (Arm C)
Title
Change in the subject Body Satisfaction Questionnaire (BSQ)
Description
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).
Time Frame
Follow-up 1: 84 days (Arm A & B); 63 days (Arm C). Follow-up 2: 140 days (Arms A & B); 119 days (Arm C)
Title
Change in Anthropometric measurements: Abdominal Circumference
Description
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).
Time Frame
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)
Title
Change in Anthropometric measurements: Abdominal Skinfold Thickness
Description
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).
Time Frame
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)
Title
Change in Anthropometric measurements: Weight
Description
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).
Time Frame
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)
Other Pre-specified Outcome Measures:
Title
Change in Abdominal Ultrasound images (optional)
Description
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.
Time Frame
Follow-up 1: 84 days (Arm A & B); 63 days (Arm C). Follow-up 2: 140 days (Arms A & B); 119 days (Arm C)
Title
Change in Abdominal Magnetic Resonance Imaging (MRI) (optional)
Description
Abdominal fat and muscle thickness (millimeters) changes from baseline to Follow-up 2 post last treatment as assessed using MRI, compared to baseline.
Time Frame
Follow-up 2: 140 days (Arms A & B); 119 days (Arm C)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Gronski, PhD
Phone
8889070115
Ext
517
Email
mgronski@venusconcept.com
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Biro, MSc
Phone
8889070115
Ext
132
Email
abiro@venusconcept.com
Facility Information:
Facility Name
Scripps Clinical Research - General Medicine
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taina LoSasso
Phone
858-554-5273
Facility Name
Schweiger Dermatology Group
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Completed
Facility Name
Tennessee Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Individual Site Status
Completed

12. IPD Sharing Statement

Learn more about this trial

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

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