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

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.

Study Overview

• Status: Terminated
• Conditions: Lipodystrophy
• Intervention / Treatment: Device: Venus Versa; Other: Glycerine gel

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Fort Lee, New Jersey, United States, 07024
      • J Dermatology and Allergy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; Group treated with the active Venus Versa octipolar applicator and the glycerine gel.	Device: Venus Versa; The Venus Versa system is a console that supports an applicators that simultaneously emits radio frequency (RF) and a Pulsed Magnetic Field (PEMF). This combination of energy can raise the temperature of treatment area quickly and homogeneously. The Pulsed Magnetic Field is induced by short pulses of electrical current through coil in the applicator. The magnetic field penetrates into the skin and results in Foucault (Eddy) electrical currents around the cell membranes of the treated tissues. Foucault currents change the electrical potential of charged receptors on the bi-lipid cell membrane layer of dermal cells, which results in the stimulation of molecular and cellular activities and reactions.; Other: Glycerine gel; Gel used to protect the skin from the RF energy and to assist with energy distribution
Sham Comparator: Control Group; Group treated with the inactive Venus Versa octipolar applicator and the glycerine gel.	Device: Venus Versa; The Venus Versa system is a console that supports an applicators that simultaneously emits radio frequency (RF) and a Pulsed Magnetic Field (PEMF). This combination of energy can raise the temperature of treatment area quickly and homogeneously. The Pulsed Magnetic Field is induced by short pulses of electrical current through coil in the applicator. The magnetic field penetrates into the skin and results in Foucault (Eddy) electrical currents around the cell membranes of the treated tissues. Foucault currents change the electrical potential of charged receptors on the bi-lipid cell membrane layer of dermal cells, which results in the stimulation of molecular and cellular activities and reactions.; Other: Glycerine gel; Gel used to protect the skin from the RF energy and to assist with energy distribution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal Circumference	Abdominal circumference measurement of the treated area at 1 month after the last treatment performed by controlled tape measurement	1 month post treatment series

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Venus Concept

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2015
• Primary Completion (Actual): October 25, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: June 19, 2015
• First Submitted That Met QC Criteria: July 6, 2015
• First Posted (Estimate): July 9, 2015

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: body fat
• Additional Relevant MeSH Terms: Metabolic Diseases; Skin Diseases; Lipid Metabolism Disorders; Skin Diseases, Metabolic; Lipodystrophy; Physiological Effects of Drugs; Protective Agents; Cryoprotective Agents; Glycerol
• Other Study ID Numbers: CS0615