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Clinical Trials in the USA / NCT05256771
Active, not recruiting Not applicable

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

NCT05256771 · tracked via the Priya Life Science USA tracker
Sponsor
Venus Concept
Phase
Not applicable
Started
2021-11-01
Last updated
2025-03-28

Condition(s) studied

Fat ReductionMuscle Tone Increased

Investigational drug(s) / intervention(s)

EMS1064 nm diode laserRF/PEMF

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

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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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 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: 1. Pregnant in the last 3 months, intending to become pregnant, postpartum or nursing in the last 6 months, including presence of post-partum diastasis. 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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Scripps Clinical Research - General Medicine San Diego California
Schweiger Dermatology Group Hackensack New Jersey
Tennessee Clinical Research Center Nashville Tennessee

More Venus Concept trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05256771 on ClinicalTrials.gov ↗ ← All trials in the USA