CoolSculpting the Upper Arm Study (ARM)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02669329|
Recruitment Status : Completed
First Posted : February 1, 2016
Results First Posted : September 17, 2020
Last Update Posted : September 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Body Fat Disorder||Device: CoolSculpting device with vacuum applicator.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CoolSculpting the Upper Arm Using a Vacuum Applicator|
|Actual Study Start Date :||February 5, 2016|
|Actual Primary Completion Date :||June 7, 2016|
|Actual Study Completion Date :||June 7, 2016|
Experimental: Upper arm treatment with vacuum applicator
Subjects with clearly visible fat sufficient for treatment received bilateral CoolSculpting treatments, 1 treatment on each arm.
Device: CoolSculpting device with vacuum applicator.
The CoolSculpting device with a vacuum applicator will be used to perform the treatments.
- Percentage of Pre-treatment Images Correctly Identified [ Time Frame: 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 of the treated areas. The review panel will consist of 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. Correct identification of photos by at least 2 of the 3 reviewers has an expected success rate of 75%.
- Safety of the CoolSculpting Device in Upper Arm Treatments [ Time Frame: 12 weeks post-treatment ]The incidence of reported unanticipated adverse device effects (UADE) from the time of enrollment through the 12-week follow-up visit will be collected and analyzed. It is expected there will be zero UADE's reported.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02669329
|Canada, British Columbia|
|Dr. Jean Carruthers Cosmetic Surgery Inc.|
|Vancouver, British Columbia, Canada, V5Z 4E1|
|Vancouver, British Columbia, Canada, V6E 4M3|