RF and PEMF Following Liposuction (NCT03588702) | Clinical Trial Compass
CompletedNot Applicable
RF and PEMF Following Liposuction
Spain50 participantsStarted 2018-07-02
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Healthy male or female older than 18 years of age but not older than 65 years of age.
✓. Having suitable area for treatment (bilateral liposuction of the back, flanks or thighs performed 8 weeks prior to study).
✓. BMI score is greater than 18.5 and less than 29.9.
✓. Willingness to refrain from a change in diet/drinking/exercise/medication regimen for the entire course of the study.
Exclusion criteria
✕. Pregnant or planning to become pregnant, having given birth (vaginal birth or Caesarean surgery) less than 9 months ago, and/or breastfeeding.
✕. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
✕. Having a permanent implant in the treated areas, such as metal plates and screws or an injected chemical substance.
✕. Having undergone any other surgery in the treated areas within 9 months of treatment or during the study.
What they're measuring
1
Improvement in skin appearance of the treated side
. 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.
✕. Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders.
✕. Having a known anti-coagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course.
✕. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.