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
45 participants
INTERVENTIONAL
2012-12-31
2014-10-31
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
TREATMENT
NONE
Study Groups
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Fat Reduction
The Zeltiq CoolSculpting System will be used to treat subcutaneous fat on each inner thigh.
The Zeltiq CoolSculpting System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Interventions
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The Zeltiq CoolSculpting System
Non-invasive 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 inner thighs and in the investigator's opinion, may benefit from the treatment.
3. Subject has not had weight change exceeding 10 pounds in the preceding month.
4. Subject with body mass index (BMI) up to 30. \[BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.\]
5. Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in his/her diet or lifestyle during the course of the study.
6. 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.
3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
4. Subject needs to administer, or has a known history of, subcutaneous injections (e.g., heparin, insulin) into the area of intended treatment 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 Raynaud'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 a bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
8. Subject is taking or has taken diet pills or supplements within the past month.
9. Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
10. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
11. Subject is pregnant or intends to become pregnant in the next 8 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
65 Years
ALL
Yes
Sponsors
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Zeltiq Aesthetics
INDUSTRY
Responsible Party
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Principal Investigators
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Suzanne Kilmer, MD
Role: PRINCIPAL_INVESTIGATOR
Laser and Skin Surgery Center of Northern California
Locations
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Laser & Skin Surgery Center of Northern California
Sacramento, California, United States
Zel Skin and Laser Specialists
Edina, Minnesota, United States
Dallas Plastic Surgery Institute
Dallas, Texas, United States
Countries
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References
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Zelickson BD, Burns AJ, Kilmer SL. Cryolipolysis for safe and effective inner thigh fat reduction. Lasers Surg Med. 2015 Feb;47(2):120-7. doi: 10.1002/lsm.22320. Epub 2015 Jan 13.
Other Identifiers
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ZA12-002
Identifier Type: -
Identifier Source: org_study_id