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