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
30 participants
INTERVENTIONAL
2016-02-05
2016-06-07
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
OTHER
NONE
Study Groups
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Upper arm treatment with vacuum applicator
Subjects with clearly visible fat sufficient for treatment received bilateral CoolSculpting treatments, 1 treatment on each arm.
CoolSculpting device with vacuum applicator.
The CoolSculpting device with a vacuum applicator will be used to perform the treatments.
Interventions
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CoolSculpting device with vacuum applicator.
The CoolSculpting device with a vacuum applicator will be used to perform the treatments.
Eligibility Criteria
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Inclusion Criteria
* Subject has clearly visible fat sufficient for treatment on the upper arm, which in the investigator's opinion, may benefit from the treatment.
* No weight change exceeding 5% in the preceding month.
* Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine during the course of the study.
* Subject has read and signed the study written informed consent form.
Exclusion Criteria
* History of prior surgery in the arms.
* Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
* Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
* History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
* History of carpal tunnel syndrome, compartment syndrome or deep vein thrombosis in the upper extremities.
* Currently taking or has taken diet pills or weight control supplements within the past month.
* Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation.
* Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
* Pregnant or intending to become pregnant in the next 5 months.
* Lactating or has been lactating in the past 6 months.
* Unable or unwilling to comply with the study requirements.
* 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.
22 Years
65 Years
ALL
Yes
Sponsors
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Zeltiq Aesthetics
INDUSTRY
Responsible Party
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Locations
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Dr. Jean Carruthers Cosmetic Surgery Inc.
Vancouver, British Columbia, Canada
Pacific Dermaesthetics
Vancouver, British Columbia, Canada
Countries
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References
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Carruthers JD, Humphrey S, Rivers JK. Cryolipolysis for Reduction of Arm Fat: Safety and Efficacy of a Prototype CoolCup Applicator With Flat Contour. Dermatol Surg. 2017 Jul;43(7):940-949. doi: 10.1097/DSS.0000000000001134.
Other Identifiers
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ZA15-005
Identifier Type: -
Identifier Source: org_study_id