Clinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen Circumference

Stopped early · Not applicable

Conditions studied: Lipodystrophy

In brief

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.

Key facts

Study ID

NCT02492997

Run by

Venus Concept

People needed

44

Starts

2015-05-14

Expected to finish

2016-10-31

Last updated by the study team

2020-11-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 significant lymphatic drainage problems.
• History of keloid scarring or of abnormal wound healing.
• History of being especially prone to bruising.
• History of epidermal or dermal disorders
• Use of isotretinoin within 6 months
• 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.
• Participation in a study of another device or drug within 1 month prior to enrollment or during this study.
• As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Where it is running

• J Dermatology and Allergy — Fort Lee, New Jersey, United States

Full record on ClinicalTrials.gov

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