CoolSculpting in the Abdomen Using Applicator With and Without CCI

Completed · Not applicable

Conditions studied: Body Fat Disorder

In brief

Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the abdomen using an applicator with the Crown Cooling Insert.

Key facts

Study ID

NCT02787850

Run by

Zeltiq Aesthetics

People needed

20

Starts

2016-04-18

Expected to finish

2016-08-31

Last updated by the study team

2021-12-03

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female subjects >22 years of age and < 65 years of age.
• 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.
• Subject has read and signed the study written informed consent form. Exclusion Criteria
• Subject has had a surgical procedure(s) in the area of intended treatment.
• 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.

Where it is running

• Bowes Dermatology Group — Miami, Florida, United States

Full record on ClinicalTrials.gov

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