Electrical Muscle Stimulation with 1064 Nm Diode Laser and RF/PEMF for Non-invasive Body Contouri… (NCT05256771) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Electrical Muscle Stimulation with 1064 Nm Diode Laser and RF/PEMF for Non-invasive Body Contouring and Fat Reduction.
United States36 participantsStarted 2021-11-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Blinded, independent photo review comparing the pre-treatment and post-treatment photographs.
Timeframe: 140 days (Arms A & B); 119 days (Arm C)
✕. Use of medications, herbs, food supplements, and vitamins known to induce photosensitivity to light exposure at the wavelength used or history of photosensitivity disorder.