Venus Bliss for Fat Loss

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new non-invasive treatment called Venus Bliss, which uses laser, radiofrequency, and electromagnetic fields to reduce unwanted fat on the belly and sides. Researchers aim to evaluate how effectively this combination slims these areas without surgery. Individuals with extra fat in these spots who have not had recent surgeries there may find this trial suitable. Participants should not change their diet or lifestyle during the study. As an unphased trial, this study provides a unique opportunity to explore innovative fat-reduction methods without surgery.

Do I need to stop taking my current medications for the trial?

You may need to stop certain medications, especially if they are antiplatelet, anticoagulant, thrombolytic, or anti-inflammatory drugs, as these should not be used within 2 weeks of treatment. If you are taking medications that cause photosensitivity, you might also need to stop those. It's best to discuss your specific medications with the trial team.

What prior data suggests that this method is safe for non-invasive fat reduction?

Research has shown that the Venus Bliss treatment, which uses a special laser, is safe and generally well-tolerated. Studies indicate that just one session with this laser can effectively reduce unwanted belly fat, with only minor side effects. The device includes a cooling feature to keep the skin comfortable and safe during treatment.

The Venus Bliss system is approved for reducing fat in the belly and sides without surgery for individuals with a Body Mass Index (BMI) of 30 or less. This approval means it meets safety standards set by health authorities for this purpose. Importantly, tests have demonstrated that the system is as safe and effective as other similar devices available. Overall, Venus Bliss appears to be a safe choice for those considering non-surgical fat reduction. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Venus Bliss for non-invasive fat reduction because it combines a 1060 nm diode laser with PEMF (pulsed electromagnetic fields) and vacuum-assisted multipolar radiofrequency (MP RF). Unlike traditional options like liposuction, which are invasive, Venus Bliss offers a non-invasive approach, reducing risks and recovery time. The innovative combination of technologies aims to enhance fat reduction by using heat and electromagnetic energy to target and break down fat cells more effectively. This multifaceted approach not only promises a more comfortable experience but also potentially delivers faster and more noticeable results compared to some existing non-invasive treatments.

What evidence suggests that this device is effective for non-invasive fat reduction?

Research shows that Venus Bliss, a non-invasive treatment, effectively reduces fat in the belly and sides. Studies have found an average reduction of about 8.55% in belly fat, with some individuals experiencing up to a 20% reduction after 12 weeks. Additionally, patients have lost up to 0.98 inches (2.5 cm) in the treated areas. Venus Bliss uses a special laser to heat fat cells, causing them to break down and be naturally removed by the body. This treatment is considered safe and effective, with the best results typically appearing three to six months after treatment. ^{4 6 7 8 9}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8438592/

Clinical Evaluation of the Safety and Efficacy of a 1060-nm ... Patients had a mean 8.55% (1.28 mm) and median 9.8% reduction in the abdominal fat layer seen at 12 weeks post-treatment and up to a 20% ...

2. venus.ai venus.ai/venus-bliss

Venus Bliss™ | Non-Invasive Laser Lipolysis Machine Venus Bliss™ is a non-invasive laser lipolysis machine for safe, effective fat reduction in the abdomen and flanks. Learn more about this advanced ...

3. drskinmedspa.com drskinmedspa.com/how-long-does-it-take-to-see-results-from-venus-bliss/

How Long Does It Take to See Results From Venus Bliss MAX Although Venus Bliss MAX™ is relatively new to the cosmetic industry, it has been shown in clinical studies to result in a reduction of up to 0.98 inches (2.5 ...

4. venusconcept.com venusconcept.com/reports/TheSkinnyOnNonInvasiveFatReduction.pdf

THE SKINNY ON NON-INVASIVE FAT REDUCTION: The applicator also provides superior power distribution, so heating is more homogenous throughout the treatment area. More even heat distribution supports.

5. venustreatments.com venustreatments.com/en-us/venus-bliss.htm

Venus Bliss™ Fat Treatments Every patient is unique; however, a Venus Bliss™ treatment may be effective with just one treatment. Optimal results will be seen three to six months after ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K190743.pdf

Venus Concept USA Inc. Elissa Burg Regulatory Consultant ... The laser applicators have an integrated contact skin cooling system to enhance safety and comfort of the treatment. In addition, the Venus ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K220592.pdf

April 27, 2022 Venus Concept USA Inc. William Mcgrail VP ... The performance testing data demonstrates that Venus BlissMAX System is as safe and effective as the legally marketed primary predicate and ...

8. irp.cdn-website.com irp.cdn-website.com/44aa0f6d/files/uploaded/vbl_whitepaper.pdf

safety and efficacy of a 1064nm diode laser, pulsed ... The Venus Bliss™ is a medical device that is approved for non-invasive lipolysis in the abdomen and flanks in individuals with a Body Mass Index of 30 or less.

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/lsm.23654

Clinical evaluation of the safety and efficacy of a 1064 nm ... The major exclusion criteria were: pregnancy, any previous liposuction/liposculpture and/or surgery in the treatment area in the last 12 months, ...