MedTrace Logo

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

NCT02492997 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-11-17

Study results available
· View outcomes & findings →

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

Interventions

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

Sponsors & Collaborators

  • Venus Concept

    lead INDUSTRY

Principal Investigators

  • Tracey L Mancuso · Venus Concept

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-14
Primary Completion
2016-10-25
Completion
2016-10-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02492997 on ClinicalTrials.gov