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

Not Applicable

Terminated

Conditions: Lipodystrophy

Interventions: Device: Venus Versa
Other: Glycerine gel

Registration Number: NCT02492997

Lead Sponsor: Venus Concept

Brief 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.

Detailed Description: This is a multi-site, prospective, controlled, randomized, double blinded clinical trial. This study is designed to evaluate the safety and efficacy of a series of treatments using the Venus Versa Octipolar applicator. Up to 60 healthy subjects at 10 sites shall be recruited by the investigator from within the investigator's subject population. Subjects shall have abdomen circumference to reduce for the designated treatment area.

Each subject will undergo 6 treatments at an interval of one treatment per week for six consecutive weeks. There will be a one month follow up which will occur 4 weeks after the 6th treatment.

At the first treatment visit, the investigator will collect demographic and medical information and randomization will take place. Subjects have an equal opportunity to be selected for the treatment or the control group.

The duration of the treatment session will be approximately 60 minutes. Expected immediate response includes temporary mild to moderate erythema and/or edema. Skin safety assessments will be conducted by the investigator after each treatment session and at the follow-up visit.

Photography will be conducted at baseline, the beginning of 4th \& 6th treatment and at 1 month follow up visit. Subjects will be asked to complete a questionnaire after each treatment and at the one month follow up visit.

Circumference measurements will be conducted at base line, before each treatment and at follow up visit. The treatment will be considered successful if the treated area circumference, reduces by at least 2.5 cm.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 44

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 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group	Glycerine gel	Group treated with the active Venus Versa octipolar applicator and the glycerine gel.
Control Group	Glycerine gel	Group treated with the inactive Venus Versa octipolar applicator and the glycerine gel.
Treatment Group	Venus Versa	Group treated with the active Venus Versa octipolar applicator and the glycerine gel.
Control Group	Venus Versa	Group treated with the inactive Venus Versa octipolar applicator and the glycerine gel.

Primary Outcome Measures

Name	Time	Method
Abdominal Circumference	1 month post treatment series	Abdominal circumference measurement of the treated area at 1 month after the last treatment performed by controlled tape measurement

Secondary Outcome Measures

Name	Time	Method
Subject Satisfaction With Treatment	1 month post treatment series	Subject 5-point Likert Satisfaction Assessment Scale where 4 = Very satisfied; 3 = Satisfied; 2 = Having no opinion; 1 = Unsatisfied and 0 = Very unsatisfied.