DualSculpting the Upper Arms (ARM)
|ClinicalTrials.gov Identifier: NCT02939105|
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : June 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Body Fat Disorder||Device: The ZELTIQ System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||DualSculpting the Upper Arms Using Vacuum Applicators and a Customized Treatment Approach|
|Actual Study Start Date :||December 2, 2016|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
Experimental: Fat Reduction
The treatments are designed to see if the fat, on the upper arm, can be reduced.
Device: The ZELTIQ System
The CoolSculpting machine will be used to perform the treatments.
- Blinded independent review of photographs to assess change in visible arm fat between baseline (pre-treatment) and 12 weeks post treatment. [ Time Frame: 12 weeks post treatment ]The primary efficacy endpoint of the study will be determined by correct identification of baseline (pre-treatment) vs. 12 weeks post-final treatment photographs by at least two out of three blinded, independent reviewers. Success will be defined as at least 70% correct identification of the baseline (pre-treatment) photographs.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02939105
|Canada, British Columbia|
|Vancouver, British Columbia, Canada, V6E 4M3|
|Principal Investigator:||Jason Rivers, MD||Pacific Dermaesthetics|