Non-Invasive Reduction of Abdominal Fat (JUNO)
This study is being performed to reduce unwanted abdominal fat using a new applicator for the Zeltiq System.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator|
- The primary effectiveness endpoint is the correct identification of the series of pre-treatment images by three independent reviewers. It is expected that the percentage of correct identification of the pre-treatment images will be at least 80%. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]The pre and post treatment images will be reviewed by three qualified and independent reviewers. The reviewers will be asked to select the pre-treatment images. The success rate is defined at the correct selection of the pre-treatment images. The expected success rate is 80%.
- Reduction in the fat layer thickness of the treated area [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Reduction in the fat layer thickness, as demonstrated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements
- Subject Satisfaction [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit.
|Study Start Date:||April 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Device: The Zeltiq System
The primary objective of the study is to achieve a discernable change to the contour of the abdominal area treated with the JUNO applicator that is consistent with that documented during a clinical study of a previous applicator used to treat lovehandles.
|United States, California|
|Laser and Skin Surgery of Northern California|
|Sacramento, California, United States, 95816|
|United States, Florida|
|Flor Mayoral, M.D.|
|Coral Gables, Florida, United States, 33143|
|United States, Maryland|
|Maryland Laser, Skin and Vein Institute|
|Hunt Valley, Maryland, United States, 21030|
|United States, Massachusetts|
|Skin Care Physicians of Chestnut Hill|
|Chestnut Hill, Massachusetts, United States, 02467|
|United States, Minnesota|
|Zel Skin and Laser Specialist LLC|
|Edina, Minnesota, United States, 55424|