Extended Follow-Up Study for Subjects Who Participated in 2010 Study (JUNO)
This study is being performed to follow up on subjects who participated in the initial study (ZA10-001) in 2010.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator|
- Independent Photo Review [ Time Frame: 12+ mos post treatment ] [ Designated as safety issue: No ]The primary effectiveness endpoint is the correct identification of the series of pre-treatment images by the three reviewers.
- Access reduction [ Time Frame: 12+ mos post treatment ] [ Designated as safety issue: No ]Reduction in the fat layer thickness
- Subject Satisfaction [ Time Frame: 12+ mos post treatment ] [ Designated as safety issue: No ]Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the follow up visit.
|Study Start Date:||March 2012|
|Study Completion Date:||February 2013|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Device: The Zeltiq System
The primary objective of this investigation is to assess the durability of treatment outcomes with the ZELTIQ System.