RF and PEMF Following Liposuction
Condition: Lipolysis
Study type: Interventional

Summary: 
      The Venus Legacy LB2 Body applicator is intended for circumference reduction treatment by
      reducing fat cell size and enhancing collagen synthesis as the result of thermal and
      non-thermal collagen stimulation. This is an open-label, evaluator-blind study of the safety
      and performance of radiofrequency (RF) and pulsed electromagnetic field (PEMF) therapy
      following liposuction. The study will enroll up to 50 male and female subjects requesting
      treatment of the back, flanks and/or thighs to improve appearance following liposuction.
      Subjects will receive a total of six study treatments to one side of their body (back, flanks
      and/or thighs) at one week intervals. Subjects will be followed up at one month after their
      last study treatment. Treatment outcomes will be compared to the non-treated side.
    

Detailed description: 
      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.
    

Intervention name(s): RF and PEMF treatment
Intervention type(s): Device
Intervention description(s): Treatment with Venus Legacy LB2 body applicator
Other intervention name(s): Venus Legacy LB2 Body applicator
Intervention model: Single Group Assignment
Intervention model description: Subjects act as their own control.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: radiofrequency; pulsed electro-magnetic fields; liposuction