Non-invasive Cooling of Subcutaneous Fat
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ClinicalTrials.gov Identifier: NCT00762307 |
Recruitment Status
:
Completed
First Posted
: September 30, 2008
Last Update Posted
: January 6, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Reduction of Unwanted Fat | Device: Zeltiq Dermal Cooling Device | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 192 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | January 2007 |
Actual Primary Completion Date : | January 2012 |
Actual Study Completion Date : | January 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Device: Zeltiq Dermal Cooling Device
Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
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- Reduction in the fat layer thickness [ Time Frame: 2 months, 6 months ]
- Subject satisfaction [ Time Frame: 2 months, 6 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female subjects > 18 years of age.
- Subject has clearly visible fat on the flanks, thighs, abdomen, or back.
- Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month.
- Subject has read and signed a written informed consent form.
Exclusion Criteria:
- Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years.
- Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months.
- Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- Subject is taking diet pills within the past 6 months.
- Subject is unable or unwilling to comply with the study requirements.
- Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Patient is pregnant or intending to become pregnant in the next 9 months.
- Patient is lactating or has been lactating in the past 9 months.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762307
United States, California | |
Investigational Site | |
Dublin, California, United States | |
Investigational Site | |
Fremont, California, United States | |
Investigational Site | |
Pleasanton, California, United States | |
Investigational Site | |
San Ramon, California, United States |
Responsible Party: | Zeltiq Aesthetics |
ClinicalTrials.gov Identifier: | NCT00762307 History of Changes |
Other Study ID Numbers: |
JM07001 |
First Posted: | September 30, 2008 Key Record Dates |
Last Update Posted: | January 6, 2012 |
Last Verified: | January 2012 |