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
40 participants
INTERVENTIONAL
2013-01-31
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Outer Thigh CoolSculpting Treatment
Treatment with the CoolSculpting System and a modified belt applicator will be performed on one outer thigh; the remaining thigh is considered the untreated control. Subjects will receive one cooling cycle applied to the thigh area intended for treatment with a protocol-defined cooling rate and duration of 120 minutes.
The Zeltiq System with Modified Belt Applicator
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Interventions
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The Zeltiq System with Modified Belt Applicator
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
* Subject has clearly visible fat on intended treatment area (outer thighs), which in the investigator's opinion, may benefit from the treatment(s).
* Subject has not had weight change exceeding 10 pounds in the preceding month.
* 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.
* 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.
* Subject has read and signed a written informed consent form.
Exclusion Criteria
* Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment.
* Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
* Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
* Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
* 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.
* 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.
* Subject is taking or has taken diet pills or supplements within the past month.
* 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).
* Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
* Subject is pregnant or intending to become pregnant in the next 8 months.
* Subject is lactating or has been lactating in the past 6 months.
* Subject is unable or unwilling to comply with the study requirements.
* Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
* 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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Eric Bachelor, MD
Role: PRINCIPAL_INVESTIGATOR
Innovation Research Center
Locations
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Marina Plastic Surgery
Marina del Rey, California, United States
Innovation Research Center
Pleasanton, California, United States
Countries
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Related Links
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Cryolipolysis Conformable-Surface Applicator for Nonsurgical Fat Reduction in Lateral Thighs
Other Identifiers
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ZA12-009
Identifier Type: -
Identifier Source: org_study_id