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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

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:

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.

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

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

NCT ID

NCT05256771

First Posted

February 3, 2022

Last Updated

May 31, 2023

Sponsor

Venus Concept

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

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

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 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

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

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

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

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

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

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

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

mgronski@venusconcept.com

First Name & Middle Initial & Last Name or Official Title & Degree

Andrea Biro, MSc

Phone

8889070115

Ext

132

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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