Non-invasive Cooling of Subcutaneous Fat

Zeltiq Aesthetics

Status: Completed

Conditions: Fat Disorder

Treatments: Device: Zeltiq Dermal Cooling Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00762307

JM07001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Treatment Group 1

Experimental group

Description:

Cooling Intensity Factor = 33 Duration = 60 minutes

Treatment:

Device: Zeltiq Dermal Cooling Device

Treatment Group 2

Experimental group

Description:

Cooling Intensity Factor = 37 Duration = 30 minutes

Treatment:

Device: Zeltiq Dermal Cooling Device

Treatment Group 3

Experimental group

Description:

Cooling Intensity Factor = 37 Duration = 45 minutes

Treatment:

Device: Zeltiq Dermal Cooling Device

Treatment Group 4

Experimental group

Description:

Cooling Intensity Factor = 42 Cooling Duration = 30 minutes

Treatment:

Device: Zeltiq Dermal Cooling Device