Clinical trial NCT02554760: Bilateral; Flank Study With Crown Cooling Insert
Official title: CoolSculpting the Flank 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: 2015-09-18
Enrollment: 19
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flank using an applicator with and without the Crown Cooling Insert.

Detailed description: This study will evaluate the Zeltiq CoolSculpting System when used with the standard CoolCore applicator and the CoolCore Applicator and the Crown Cooling Insert accessory.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects \> 22 years of age and \< 65 years of age.
* Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
* No weight change exceeding 5% of body weight 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%) 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, 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 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.
* 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 Correctly Identified Pre-treatment Photos by a Panel of Blinded Independent Reviewers
timeFrame: 12 weeks post-treatment
measure: Safety of the Zeltiq CoolSculpting System Using the CoolCore Applicator With and Without the Crown Cooling Insert
timeFrame: Enrollment through the 12 week post-treatment follow-up visit
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: 12 weeks post-treatment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser and Skin Surgery of Northern California
state: California
Study officials:
affiliation: Laser and Skin Surgery Center of Northern California
name: Suzanne Kilmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kilmer SL. Prototype CoolCup cryolipolysis applicator with over 40% reduced treatment time demonstrates equivalent safety and efficacy with greater patient preference. Lasers Surg Med. 2017 Jan;49(1):63-68. doi: 10.1002/lsm.22550. Epub 2016 Jun 21.