Clinical trial NCT02787850: CoolSculpting in the Abdomen Using Applicator With and Without CCI
Official title: CoolSculpting the Abdomen Using an Applicator With a Crown Cooling Insert
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Fat Disorder
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2016-06-01
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Detailed description: Evaluation of CoolSculpting treatment in the abdomen using a vacuum applicator with an accessory insert.

Eligibility criteria: Inclusion Criteria

* 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.

Primary outcomes:
measure: Percentage of Accurately Identified Pre-treatment Photos
timeFrame: 12 weeks post treatment
measure: Participants With Unanticipated Adverse Device Effects (UADE)
timeFrame: Enrollment through 12 weeks post-treatment
Secondary outcomes:
measure: Subject Satisfaction Questionnaire
timeFrame: 12 weeks post-final treatment
Other outcomes:
Locations:
city: Miami
country: United States
facility: Bowes Dermatology Group
state: Florida
Study officials:
affiliation: Bowes Dermatology Group
name: Leyda Bowes, MD
role: PRINCIPAL_INVESTIGATOR
References: