Clinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen Circumference (NCT02492997) | Clinical Trial Compass
TerminatedNot Applicable
Clinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen Circumference
Stopped: Trial was terminated early due to slow enrollment.
United States44 participantsStarted 2015-05-14
Plain-language summary
The octipolar applicator is intended for circumference reduction treatment by reduction of adipose size and enhancement of collagen synthesis as the result thermal and non-thermal collagen stimulation. This trial is intended to evaluate the effect of radio frequency (RF) and pulsed electromagnetic fields (PEMF) treatment on circumference reduction.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Body mass index (BMI) score is greater than 18.5 and less than 29.9 - normal to overweight, but not obese.
* Willingness to refrain from a change in diet/drinking/exercise/medication regimen for the entire course of the study.
* For female of child bearing potential - using a medically acceptable form of birth control at least 3 months prior to enrollment and during the entire course of the study (i.e., oral contraceptives, Intra Uterine Device (IUD), contraceptive implant, barrier methods with spermicide, or abstinence).
Exclusion Criteria:
* Pregnant or planning to become pregnant, having given birth less than 9 months ago, and/or breastfeeding.
* Having any active electrical implant anywhere in the body,
* Having a permanent implant in the treated areas
* Having received treatment with laser, RF or other devices in the treated areas within 6 months of treatment or during the study.
* Having undergone a liposuction surgery or any contouring treatment in the areas intended for treatment within 2 years of treatment
* Having or undergoing any form of cancer
* Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders.
* Having a anticoagulative or thromboembolic condition or taking anticoagulation medications
* History of immunosuppression/immune deficiency disorders
* Suffering from hormonal imbalance which may affect weight or cellulite
* History of signific…