Reduction of Unwanted Fat Clinical Trial
| Verified date | May 2009 |
| Source | Zeltiq Aesthetics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.
| Status | Completed |
| Enrollment | 240 |
| Est. completion date | June 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Male or female subjects > 18 years of age. 2. Subject has clearly visible fat on an area of the body appropriate for treatment with the non-invasive Zeltiq cooling device such as the flanks, thighs, abdomen or back. 3. Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month and plans to maintain their weight to within ±10 pounds over the next 6 months. 4. Subject has read and signed a written informed consent form. Exclusion Criteria: 1. Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years. 2. Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months. 3. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. 4. Subject has used diet pills within the past 6 months. 5. Subject is unable or unwilling to comply with the study requirements. 6. Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation. 7. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 8. Patient is pregnant or intending to become pregnant in the next 9 months. 9. Patient is lactating or has been lactating in the past 9 months. 10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Investigational Site | Baltimore | Maryland |
| United States | Investigational Site | Boston | Massachusetts |
| United States | Investigational Site | Chicago | Illinois |
| United States | Investigational Site | Dallas | Texas |
| United States | Investigational Site | Hackensack | New Jersey |
| United States | Investigational Site | Miami | Florida |
| United States | Investigational Site | Minneapolis | Minnesota |
| United States | Investigational Site | New York | New York |
| United States | Investigational Site | Sacramento | California |
| United States | Investigational Site | San Diego | California |
| United States | Investigational Site | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Zeltiq Aesthetics |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Visible improvement in treated area | 4 months | No | |
| Secondary | Subject satisfaction | 4 months | No |