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

NCT02492997 | Terminated Results DMC

• 1 other identifier: CS0615
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipodystrophy

Keywords

body fat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Subject Satisfaction With Treatment

  1 month post treatment series

Study Arms (2)

Treatment Group

EXPERIMENTAL

Group treated with the active Venus Versa octipolar applicator and the glycerine gel.

Device: Venus Versa; Other: Glycerine gel

Control Group

SHAM COMPARATOR

Group treated with the inactive Venus Versa octipolar applicator and the glycerine gel.

Device: Venus Versa; Other: Glycerine gel

Interventions

Venus Versa DEVICE

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.

Control Group; Treatment Group

Glycerine gel OTHER

Gel used to protect the skin from the RF energy and to assist with energy distribution

Control Group; Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

J Dermatology and Allergy

Fort Lee, New Jersey, 07024, United States

Location

MeSH Terms

Conditions

Lipodystrophy

Condition Hierarchy (Ancestors)

Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

The trial commenced March 14, 2015 and was closed on October 25, 2016. The trial was terminated early due to insufficient recruitment.

Results Point of Contact

• Title: Dr. Yoni Iger
• Organization: Venus Concept Ltd.

yoni@venusconcpet.com

888-907-0115

Study Officials

• Tracey L Mancuso

  Venus Concept

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2015
• First Posted: July 9, 2015
• Study Start: May 14, 2015
• Primary Completion: October 25, 2016
• Study Completion: October 31, 2016
• Last Updated: November 17, 2020
• Results First Posted: November 17, 2020

Record last verified: 2020-11

Locations

US (1)