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

NCT05256771 | Active Not Recruiting FDA Device

• 1 other identifier: BL0221
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

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.

Conditions

Fat Reduction; Muscle Tone Increased

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Blinded Investigator review comparing the pre-treatment photographs and post-treatment Follow-up live assessment.

  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)

  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

  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

  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

  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 Outcomes (2)

• Change in Abdominal Ultrasound images (optional)

  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)

  Follow-up 2: 140 days (Arms A & B); 119 days (Arm C)

Study Arms (3)

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).

Device: EMS; Device: 1064 nm diode laser; Device: RF/PEMF

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).

Device: EMS; Device: RF/PEMF

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).

Device: EMS

Interventions

EMS DEVICE

Abdominal muscle stimulation using EMS

Arm A: Full Treatment Arm (Laser + EMS + RF/PEMF); Arm B: EMS/RF Arm (EMS + RF/PEMF); Arm C: EMS Arm (EMS only)

1064 nm diode laser DEVICE

Adipose tissue heating using 1064 nm diode laser

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

RF/PEMF DEVICE

Collagen re-modelling and reduction in subcutaneous fat using RF/PEMF

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (3)

Scripps Clinical Research - General Medicine

San Diego, California, 92121, United States

Location

Schweiger Dermatology Group

Hackensack, New Jersey, 07601, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

MeSH Terms

Conditions

Muscle Hypertonia

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 25, 2022
• Study Start: November 1, 2021
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)