EMS + Laser + RF/PEMF for Fat Loss

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Venus Concept

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

This trial is for men and women aged 18-65 with a BMI of ≤30 kg/m2 who are not currently changing their abdominal exercise routine. Participants must consent to the study's terms and cannot have had recent surgery or skin conditions in the treatment area, be pregnant or nursing, have immune deficiencies, bleeding disorders, certain chronic diseases, tattoos in the treatment area, or be on drugs that affect bleeding or cause light sensitivity.

Inclusion Criteria

You promise not to do any new exercises that focus on your abdomen during the study.

Your body mass index (BMI) is less than or equal to 30, which will be checked before the study starts.

You have read and signed a paper that explains the study and your involvement in it.

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Exclusion Criteria

You have significant skin problems in the area where the treatment would be given, like open wounds, sores, or infections.

Enrolled in a clinical study of any other investigational drug or device

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

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Treatment Details

Interventions

1064 nm diode laser (Device)
EMS (Device)
RF/PEMF (Device)

Trial OverviewThe study tests electrical muscle stimulation (EMS), a 1064 nm diode laser, pulsed electromagnetic field (PEMF), and radio frequency (RF) treatments using Venus Bliss Max for non-invasive body contouring and fat reduction. It's a multi-center trial where participants are randomly assigned to one of three groups without knowing which group they're in.

Participant Groups

3Treatment groups

Active Control

Group I: Arm A: Full Treatment Arm (Laser + EMS + RF/PEMF)Active Control3 Interventions

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).

Group II: Arm B: EMS/RF Arm (EMS + RF/PEMF)Active Control2 Interventions

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).

Group III: Arm C: EMS Arm (EMS only)Active Control1 Intervention

Arm C: Subjects will receive weekly electrical muscle stimulation treatments at days 0, 7, 14, 21, 28 and 35 (±2 days).