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RF and PEMF Following Liposuction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03588702
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
Venus Concept

Brief 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.

Condition or disease Intervention/treatment Phase
Lipolysis Device: RF and PEMF treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
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
Primary Purpose: Treatment
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

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male or female older than 18 years of age but not older than 65 years of age.
  2. Having suitable area for treatment (bilateral liposuction of the back, flanks or thighs performed 8 weeks prior to study).
  3. BMI score is greater than 18.5 and less than 29.9.
  4. Willingness to refrain from a change in diet/drinking/exercise/medication regimen for the entire course of the study.

Exclusion Criteria:

  1. Pregnant or planning to become pregnant, having given birth (vaginal birth or Caesarean surgery) less than 9 months ago, and/or breastfeeding.
  2. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
  3. Having a permanent implant in the treated areas, such as metal plates and screws or an injected chemical substance.
  4. Having undergone any other surgery in the treated areas within 9 months of treatment or during the study.
  5. Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
  6. Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders.
  7. Having a known anti-coagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course.
  8. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
  9. Suffering from hormonal imbalance which may affect weight or cellulite.
  10. History of significant lymphatic drainage problems.
  11. Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions and active cold sores or herpes sores prior to treatment or during the treatment course.
  12. History of keloid scarring or of abnormal wound healing.
  13. History of being especially prone to bruising.
  14. History of epidermal or dermal disorders (particularly if involving collagen or micro-vascularity).
  15. Use of oral retinoids (e.g. isotretinoin (Accutane®)) within 6 months of treatment or during the study.
  16. Use of anti-cellulite creams within a month of treatment or during the course of the study.
  17. Significant change in diet or exercise regimen within a month of enrollment or during this study and/or weight loss or gain of 10 lbs. (4.5 kgs) within 2 months of enrollment or during this study.
  18. Participation in a study of another device or drug within 1 month prior to enrollment or during this study.

Information from the National Library of Medicine

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


Contacts
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Contact: Andrea Biro, MSc 888-907-0115 ext 132 abiro@venusconcept.com
Contact: Louie Cabigao 888-907-0115 ext 127 lcabigao@venusconcept.com

Locations
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Spain
Ocean Clinic Recruiting
Marbella, Spain
Contact: Vanessa Garcia Sierra    (+34) 951 775 518    info@oceanclinic.net   
Sponsors and Collaborators
Venus Concept
Investigators
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Study Director: Paul Cardarelli Venus Concept
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Responsible Party: Venus Concept
ClinicalTrials.gov Identifier: NCT03588702    
Other Study ID Numbers: CS0817
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Venus Concept:
radiofrequency
pulsed electro-magnetic fields
liposuction