NCT02492997

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Venus Concept · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lipodystrophy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-05-14
• Primary completion: 2016-10-25
• Completion: 2016-10-31
• First posted: 2015-07-09
• Last updated: 2020-11-17
• Results posted: 2020-11-17

Locations

1 site across 1 country: United States