Clinical trial NCT00762437: Non-Invasive Cooling of Fat Cells
Official title: A Prospective Clinical Study of Non-Invasive Cooling of Subcutaneous Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reduction of Unwanted Fat
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Visible Improvement in Treated Area
timeFrame: 4 months
Secondary outcomes:
measure: Participant Satisfaction
timeFrame: 4 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: Washington
country: United States
facility: Investigational Site
state: District of Columbia
city: Miami
country: United States
facility: Investigational Site
state: Florida
city: Chicago
country: United States
facility: Investigational Site
state: Illinois
city: Baltimore
country: United States
facility: Investigational Site
state: Maryland
city: Boston
country: United States
facility: Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: Investigational Site
state: Minnesota
city: Hackensack
country: United States
facility: Investigational Site
state: New Jersey
city: New York
country: United States
facility: Investigational Site
state: New York
city: Dallas
country: United States
facility: Investigational Site
state: Texas
Study officials:
References: