VelaShape III Device in Comparison to Cryolipolysis for Circumferential Reduction (NCT02143960) | Clinical Trial Compass
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 range
18 Years – 60 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.