Clinical Evaluation of a 1060 nm Diode Laser, PEMF and Vacuum Assisted MP RF for Non-invasive Fat Reduction

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Venus Concept

Must not be taking: Antiplatelets, Anticoagulants, Retinoids, others

Disqualifiers: Pregnancy, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 16 weeks

39 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a non-surgical method using a special laser, electromagnetic waves, and a suction device with radio waves to reduce belly and side fat. It targets people looking for non-invasive fat reduction. The laser heats and destroys fat cells, while the other devices help tone muscles and break down fat.

Who Is on the Research Team?

Yoni Iger, PhD

Principal Investigator

Venus Concept LTD

Are You a Good Fit for This Trial?

Inclusion Criteria

3. BMI score is less than 35. 4. Agree to not making any major changes in their diet or lifestyle during the course of the study.

5. Able and willing to comply with the treatment/follow-up schedule and requirements.

6. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study, and have a negative Urine Pregnancy test at baseline.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3 diode laser treatments and 3 pulsed electromagnetic fields and vacuum assisted radio frequency treatments

16 weeks

3 visits (in-person) at Week 0, 8, and 16

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

1 visit (in-person) at Week 24

What Are the Treatments Tested in This Trial?

Interventions

• Venus Bliss

How Is the Trial Designed?

Group I: Subject treatment group Experimental Treatment 1 Intervention

Treatment group receiving 3 diode treatments and 3 RF/PEMF treatments at Week 0, 8 and 16 with a follow-up at Week 24.

Who Is Running the Clinical Trial?

Venus Concept

Lead Sponsor

Trials

35

Recruited

1,300+