RF and PEMF Following Liposuction
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|ClinicalTrials.gov Identifier: NCT03588702|
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : August 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Lipolysis||Device: RF and PEMF treatment||Not Applicable|
Adipose tissue is a loose type of connective tissue specialized to store lipids. The majority of lipids stored in adipose cells are triglycerides formed from imported free fatty acids and glycerol. It is not uniformly distributed in the body. The major adipose depot is subcutaneous (about 80% of all body fat).
The technology options for skin tightening and body contouring have included vacuum massage, infrared laser energy, high frequency focused ultrasound, cryolipolysis, radiofrequency energy and various hybrid energy device options. Radiofrequency energy devices have remained the most common and dominant technology in the noninvasive management of skin tightening, cellulite improvement and body contouring enhancement, as they can treat all these conditions with relatively consistent results.
The RF energy is high frequency alternating electrical current that passes into the dermis and hypodermal tissues without disruption of the epidermal-dermal barrier. The high frequency oscillating electrical current results in collisions between charged molecules and ions and the micromolecular mechanical energy from these collisions is transformed into heat. This biological RF heat occurs irrespective of chromophore or skin type and is not dependent upon selective photothermolysis. The RF heat has different biological and hence, clinical effects, depending upon the tissue targeted. In the dermis, where the primary cellular element is the fibroblast and the extracellular matrix (ECM) is comprised of collagen, elastin and ground substances, the RF mediated thermal stimulation of the ECM results in an immediate and temporary shrinkage of the collagen triple helix. Further, the RF thermal stimulation results in a microinflammatory stimulation of the fibroblast which in response produces new collagen (neocollagenesis) and new elastin neoelastogenesis), and ground substances. RF thermal stimulation of adipose tissue results in a thermal mediated stimulation and augmented activity of lipase mediated enzymatic degradation of adipocyte derived triglycerides into free fatty acids and glycerol. This amplification of the physiologic breakdown and egress of the triglycerides out of the adipocyte, while keeping the adipocyte cell membrane and cell function intact, results in RF induced shrinkage of the fat cells and body contouring.
The Venus Legacy LB2 Body Applicator Combines Multi-Polar RF current and Pulsed Electromagnetic Fields (PEMF) in synergy with suction/vacuum. PEMF has been shown to increase fibroblast derived collagen production through a non-thermal mechanism of membrane stimulation, and the stimulation of fibroblast mediated angiogenesis which facilitates and enhances wound healing in tissues. Theoretically then, the synergistic RF and PEMF would create RF thermal collagen stimulation and PEMF non-thermal stimulation of collagen, RF thermally mediated reduction in adipocyte size and PEMF micro-tissue healing effects to minimize edema, swelling and downtime that are associated with pure RF thermal therapies.
The objective of this clinical study is to evaluate the safety and performance of RF and PEMF using the Venus Legacy LB2 body applicator following liposuction to the back, flanks and/or thighs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Subjects act as their own control.|
|Masking:||None (Open Label)|
|Masking Description:||Independent blinded reviewers to view photographs to assess improvement of skin appearance of the treated side at 1 month post-treatment using the General Aesthetic Improvement Scale (GAIS) compared to the non-treated side|
|Official Title:||Clinical Evaluation of the Safety and Performance of RF and PEMF Following Liposuction|
|Actual Study Start Date :||July 2, 2018|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: Venus Legacy LB2 Body applicator group
Liposuction area is divided into 2 equal sections. One section receives RF and PEMF treatment.
Device: RF and PEMF treatment
Treatment with Venus Legacy LB2 body applicator
Other Name: Venus Legacy LB2 Body applicator
- Improvement in skin appearance of the treated side [ Time Frame: One month after last treatment ]Using the General Aesthetic improvement scale (GAIS), blinded reviewers assess photos of liposuction area to determine improvement in treated side as compared to non-treated side where 3 is very much improved; 2 is much improved; 1 is imporved; 0 is no change; -1 is worse; -2 is much worse and -3 is very much worse.
- Improvement in skin elasticity of the treated side [ Time Frame: One month after last treatment ]As measured by a cutometer, determine improvement in skin elasticity of the treated side as compared to the non-treated side where parameter R2, gross elasticity is used. The closer the value is to 1 (100%), the more elastic the skin.
- Subject satisfaction of treatment [ Time Frame: One month after last treatment ]Using the 5-point Likert Satisfaction scale, subjects indicate their satisfaction with the appearance of the treated side as compared to non-treated side where 0 is very unsatisfied; 1 is unsatisfied; 2 is having no opinion; 3 is satisfied and 4 is very satisfied.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588702
|Contact: Andrea Biro, MSc||888-907-0115 ext firstname.lastname@example.org|
|Contact: Louie Cabigao||888-907-0115 ext email@example.com|
|Contact: Vanessa Garcia Sierra (+34) 951 775 518 firstname.lastname@example.org|
|Study Director:||Paul Cardarelli||Venus Concept|