CoolSculpting in the Abdomen Using Applicator With and Without CCI
NCT ID: NCT02787850
Last Updated: 2021-12-03
Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2016-04-18
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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CoolSculpting Treatment Cohort A
Cohort A will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 60 minutes using the CoolMax applicator without the Crown Cooling Insert. The contralateral side (Abdominal side 2) will be treated with the Crown Cooling Insert at a second protocol-defined temperature for 45 minutes.
Each half of the abdominal area will be treated once, for a total of two treatments per subject.
CoolSculpting Treatment
The CoolSculpting device will be used to perform treatments.
CoolSculpting Treatment Cohort B
Cohort B will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 45 minutes using the CoolMax applicator with the Crown Cooling Insert. The contralateral side (Abdominal side 2) will be treated with a second protocol-defined temperature for 60 minutes with the Crown Cooling Insert.
Each half of the abdominal area will be treated once, for a total of two treatments per subject.
CoolSculpting Treatment
The CoolSculpting device will be used to perform treatments.
Interventions
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CoolSculpting Treatment
The CoolSculpting device will be used to perform treatments.
Eligibility Criteria
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Inclusion Criteria
* Subject has clearly visible fat on the abdomen, which in the investigator's opinion, may benefit from the treatment.
* Subject is a candidate for a standard CoolSculpting treatment with a CoolMax applicator.
* No weight change exceeding 5% of body weight in the preceding month.
* Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine during the course of the study.
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 12 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, cold agglutinin disease 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 or any other metal containing implant.
* Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).
* Subject is lactating or has been lactating in the past 6 months.
* Subject has a history of hernia in the areas to be treated.
* 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.
* Subject is prone to severe claustrophobia (during MRI scans).
* 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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Principal Investigators
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Leyda Bowes, MD
Role: PRINCIPAL_INVESTIGATOR
Bowes Dermatology Group
Locations
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Bowes Dermatology Group
Miami, Florida, United States
Countries
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Other Identifiers
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ZA16-002
Identifier Type: -
Identifier Source: org_study_id