Body Fat Disorder
Conditions
Keywords
Lipolysis, Cryolipolysis, Fat Reduction
Brief summary
This study is being performed to follow up on subjects who participated in the initial study (ZA10-001) in 2010.
Detailed description
The primary objective of this investigation is to assess the durability of treatment outcomes with the ZELTIQ System.
Interventions
DEVICEThe Zeltiq System
This is a follow-up study from the initial treatments performed in 2010. No additional treatments will be performed.
Sponsors
Zeltiq Aesthetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subject participated in the ZA10-001 study, and received all study treatments. 2. Subject has read and signed a written informed consent form.
Exclusion criteria
1. Subject has had any surgical or aesthetic procedure(s) in or around the abdomen since the completion of the ZA10-001 study treatments. 2. Subject is pregnant. 3. Subject is unable or unwilling to comply with the study requirements. 4. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 5. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the integrity of the data.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Independent Photo Review | 12+ mos post treatment | The primary effectiveness endpoint is the correct identification of the series of pre-treatment images by the three reviewers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Access reduction | 12+ mos post treatment | Reduction in the fat layer thickness |
| Subject Satisfaction | 12+ mos post treatment | Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the follow up visit. |
Countries
United States
Outcome results
None listed