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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02492997
• Date of registration: 19/06/2015
• Prospective Registration: No
• Primary sponsor: Venus Concept
• Public title: Clinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen Circumference
• Scientific title: Clinical Evaluation of Venus Versa Octipolar Applicator for Reduction of Abdomen Circumference
• Date of first enrolment: May 14, 2015
• Target sample size: 44
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02492997
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Tracey L Mancuso
• Affiliation: Venus Concept

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lipodystrophy

Intervention(s)

Other: Glycerine gel

Device: Venus Versa

Primary Outcome(s)

Abdominal Circumference [Time Frame: 1 month post treatment series]

Secondary Outcome(s)

Subject Satisfaction With Treatment [Time Frame: 1 month post treatment series]

Secondary ID(s)

CS0615

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/11/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02492997