CompletedNot Applicable

VelaShape III Device in Comparison to Cryolipolysis for Circumferential Reduction

United States10 participantsStarted 2013-09

Plain-language summary

The purpose of this study is to compare the clinical performance of the VelaShape III device with CoolSculpt for reduction of the waist, love handles and flanks.

Who can participate

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Informed consent process completed and subject completed consent.
✓. Fitzpatrick Skin Type I to VI
✓. Having excess fat deposits bilaterally in the waist / love-handle / flank areas.
✓. BMI score is greater than 18.5 and less than 29.9 - normal to overweight, but not obese.
✓. Willing to follow the treatment and follow-up schedule and post-treatment care instructions.
✓. Willingness to refrain from a change in diet/ exercise/medication regimen for the entire course of the study.
✓. If female, not pregnant, lactating and must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
✓. Willing to have photographs and images taken of the treated areas to be used de-identified in evaluations, publications and presentations.

Exclusion criteria

✕. Subjects with history of excessive weight fluctuation or expect to gain/lose more than 5 pounds) during the study time frame.
✕. Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding.
✕. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
✕. Having a permanent implant in the treated area, such as metal plates or an injected chemical substance such as silicone.
✕. Known photosensitivity.
✕. Having received treatment with laser, RF or other devices in the treated areas within 6 months of treatment or during the study.
✕. Having undergone any other surgery in the treated areas within 12 months of treatment or during the study, including liposuction.
✕. Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.

What they're measuring

A blinded rating of the treatment area

Timeframe: 3 month post treatment

Trial details

NCT IDNCT02143960

SponsorSyneron Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-09

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