Main Line Center for Laser Surgery
Ardmore, Pennsylvania, 19003, United States
NCT Number: NCT02941146
Evaluate the safety and efficacy of abdominal DualSculpting with CoolAdvantage applicators.
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Notify Me22 year–65 year
All sexes
Interventional
Not applicable
Ardmore, Pennsylvania, 19003, United States
The study will evaluate the safety and efficacy of non-invasive fat reduction in the abdomen using two applicators.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The CoolSculpting System will be used to perform the treatments with the CoolAdvantage family of applicators.
Time frame: Baseline to 12 weeks post-treatment
Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. The primary efficacy endpoint of the study was the correct identification of baseline (pre-treatment) vs. 12 weeks post-final treatment images by two out of three blinded, independent reviewers. Success was defined as at least 70% correct identification of the baseline (pre-treatment) photographs.
Time frame: 12 week post-treatment
The incidence of unanticipated adverse device effects will be measured. It is expected there will be zero UADEs.
Time frame: 12 weeks post-treatment
Subject satisfaction with the Zeltiq procedure as determined by positive responses in a subject satisfaction questionnaire administered at the 12 weeks post-treatment visit. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses, with lower numbers (e.g. 1 or 2) indicating positive responses and higher numbers indicating less positive responses.
Zeltiq Aesthetics
Industry
Acronym: DSA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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