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

Last updated: March 24, 2025
Sponsor: Venus Concept
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Limb Spasticity

Treatment

1064 nm diode laser

RF/PEMF

EMS

Clinical Study ID

NCT05256771
BL0221
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 thecourse of the study.

  3. BMI ≤ 30 kg/m2 as determined at screening.

  4. Subject has read and signed a written informed consent form.

Exclusion

Exclusion Criteria:

  1. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursingin the last 6 months, including presence of post-partum diastasis.

  2. Any previous liposuction/lipo-sculpture or any type of surgical procedure in thetreatment area in the past 12 months.

  3. History of immunosuppression/immune deficiency disorders (including AIDS and HIVinfection) or use of immunosuppressive medications last 6 months prior to and duringthe course of the study.

  4. History of hyperlipidemia, diabetes mellitus, hepatitis, blood coagulopathy orexcessive bleeding.

  5. Use of antiplatelet medications (81 mg acetylsalicylic acid daily permitted),anticoagulants, thrombolytics or anti-inflammatory medications within 2 weeks oftreatment or a history of bleeding disorders.

  6. History of skin cancer or any other cancer in the areas to be treated, includingpresence of malignant or pre-malignant pigmented lesions.

  7. Having a permanent implant in the treatment area such as metal plates or an injectedchemical substance such as silicone or parenteral gold therapy (gold sodiumthiomalate), or drug delivery system that would prevent treatment at the treatmentsite.

  8. Use of medications, herbs, food supplements, and vitamins known to inducephotosensitivity to light exposure at the wavelength used or history ofphotosensitivity disorder.

  9. Suffering from significant skin conditions in the treatment area or inflammatoryskin conditions including but not limited to open lacerations, abrasions, herpessores, 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 orlatex 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 ofthe Investigator, potentially affect the subject's response or the integrity of thedata or would pose an unacceptable risk to the subject.

Study Design

Total Participants: 36
Treatment Group(s): 3
Primary Treatment: 1064 nm diode laser
Phase:
Study Start date:
November 01, 2021
Estimated Completion Date:
September 30, 2025

Study 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.

Connect with a study center

  • Scripps Clinical Research - General Medicine

    San Diego, California 92121
    United States

    Site Not Available

  • Schweiger Dermatology Group

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Tennessee Clinical Research Center

    Nashville, Tennessee 37215
    United States

    Site Not Available

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