Clinical trial NCT00762307: Non-invasive Cooling of Subcutaneous Fat
Official title: A Prospective, Multi-Center Clinical Study of Non-Invasive Cooling of Subcutaneous Fat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Disorder
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.

Detailed description: 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 using the Zeltiq Dermal Cooling device.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects \> 18 years of age.
2. Subject has clearly visible fat on the flanks, thighs, abdomen, or back.
3. Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month.
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 is taking 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: Change in Fat Layer Thickness of the Treated Flank
timeFrame: Baseline and 6 months
measure: Percentage of Subjects Expressing Satisfaction With the Procedure
timeFrame: 6 months post-treatment follow-up visit
measure: Percentage of Correctly Identified Pre-treatment Photographs
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin
country: United States
facility: Investigational Site
state: California
city: Fremont
country: United States
facility: Investigational Site
state: California
city: Pleasanton
country: United States
facility: Investigational Site
state: California
city: San Ramon
country: United States
facility: Investigational Site
state: California
Study officials:
affiliation: Zeltiq Aesthetics
name: Kerrie Jiang
role: STUDY_CHAIR
References: