Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2010-03-30
2010-12-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Experimental: Abdomen Treatment Group
All subjects were treated on the abdomen with the CoolSculpting system.
The Zeltiq System
Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
Interventions
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The Zeltiq System
Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject has clearly visible fat on the abdomen.
3. Subject has not had weight change exceeding 10 pounds in the preceding month.
4. Subject agrees to maintain their weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
5. Subject has read and signed a written informed consent form.
Exclusion Criteria
2. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year.
3. Subject has had a non-invasive fat reduction procedure in the area of intended treatment within the past 6 months.
4. Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
6. Subject has a known history of Reynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
7. Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
8. Subject body mass index (BMI) exceeds 40. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
9. Subject is taking or has taken diet pills or supplements within the past month.
10. Subject has any dermatological conditions or scars in the location of the treatment sites that may interfere with the treatment or evaluation.
11. Subject is pregnant or intending to become pregnant in the next 6 months.
12. Subject is lactating or has been lactating in the past 6 months.
13. Subject is unable or unwilling to comply with the study requirements.
14. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
15. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
18 Years
ALL
Yes
Sponsors
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Zeltiq Aesthetics
INDUSTRY
Responsible Party
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Locations
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Laser and Skin Surgery of Northern California
Sacramento, California, United States
Flor Mayoral, M.D.
Coral Gables, Florida, United States
Maryland Laser, Skin and Vein Institute
Hunt Valley, Maryland, United States
Skin Care Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, United States
Zel Skin and Laser Specialist LLC
Edina, Minnesota, United States
Countries
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Other Identifiers
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ZA10-001
Identifier Type: -
Identifier Source: org_study_id