Electrical Muscle Stimulation with 1064 Nm Diode Laser and RF/PEMF for Non-invasive Body Contouring and Fat Reduction.
NCT ID: NCT05256771
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
36 participants
INTERVENTIONAL
2021-11-01
2025-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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).
Study Groups
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Arm A: Full Treatment Arm (Laser + EMS + RF/PEMF)
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).
EMS
Abdominal muscle stimulation using EMS
1064 nm diode laser
Adipose tissue heating using 1064 nm diode laser
RF/PEMF
Collagen re-modelling and reduction in subcutaneous fat using RF/PEMF
Arm B: EMS/RF Arm (EMS + RF/PEMF)
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).
EMS
Abdominal muscle stimulation using EMS
RF/PEMF
Collagen re-modelling and reduction in subcutaneous fat using RF/PEMF
Arm C: EMS Arm (EMS only)
Arm C: Subjects will receive weekly electrical muscle stimulation treatments at days 0, 7, 14, 21, 28 and 35 (±2 days).
EMS
Abdominal muscle stimulation using EMS
Interventions
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EMS
Abdominal muscle stimulation using EMS
1064 nm diode laser
Adipose tissue heating using 1064 nm diode laser
RF/PEMF
Collagen re-modelling and reduction in subcutaneous fat using RF/PEMF
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
Yes
Sponsors
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Venus Concept
INDUSTRY
Responsible Party
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Locations
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Scripps Clinical Research - General Medicine
San Diego, California, United States
Schweiger Dermatology Group
Hackensack, New Jersey, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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BL0221
Identifier Type: -
Identifier Source: org_study_id
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