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

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Brief Title

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

Official Title

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

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.
    


Study Type

Interventional


Primary Outcome

Abdominal Circumference

Secondary Outcome

 Subject Satisfaction With Treatment

Condition

Lipodystrophy

Intervention

Venus Versa

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

44

Start Date

May 14, 2015

Completion Date

October 31, 2016

Primary Completion Date

October 25, 2016

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Tracey L Mancuso, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02492997

Organization ID

CS0615


Responsible Party

Sponsor

Study Sponsor

Venus Concept


Study Sponsor

Tracey L Mancuso, Study Director, Venus Concept


Verification Date

November 2020