Cryolipolysis for Jawline Contouring (JAW)
|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: NCT03352141|
Recruitment Status : Active, not recruiting
First Posted : November 24, 2017
Last Update Posted : April 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Body Fat Disorder||Device: The ZELTIQ System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Non-Invasive Fat Reduction With Cryolipolysis for Jawline Contouring|
|Actual Study Start Date :||December 8, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Fat Reduction
The treatments are designed to see if the fat can be reduced along the jawline with Cryolipolysis.
Device: The ZELTIQ System
The CoolSculpting machine will be used to perform the treatments.
- Safety endpoint in relation to adverse events [ Time Frame: Through study completion, an average of 9-months. ]Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs
- Photo review [ Time Frame: 12 weeks post second treatment. ]Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers.
- Effectiveness endpoint gauged by reduction in fat layer thickness [ Time Frame: 12 weeks post second treatment. ]Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.
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): NCT03352141
|Canada, British Columbia|
|Vancouver, British Columbia, Canada, V6H 4E1|
|Study Director:||Kerrie Jiang, NP||Zeltiq Aesthetics|