Non-Invasive Cooling of Fat Cells

Not Applicable

Completed

• Conditions: Reduction of Unwanted Fat
• Interventions: Device: Zeltiq Dermal Cooling Device

• Registration Number: NCT00762437
• Lead Sponsor: Zeltiq Aesthetics

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

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-09-27
• Study First Submitted QC: 2008-09-29
• Study First Posted: 2008-09-30
• Status Verified: 2009-05
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-16
• Last Update Posted: 2011-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Zeltiq Dermal Cooling Device	-

Primary Outcome Measures

Name	Time	Method
Visible improvement in treated area	4 months

Secondary Outcome Measures

Name	Time	Method
Subject satisfaction	4 months

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 Dallas, Texas, United States