Clinical trial NCT03304925: CoolSculpting the Flanks
Official title: CoolSculpting the Flanks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Body Fat Disorder
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2017-10-09
Enrollment: 320
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 flanks.


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 8 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: Safety endpoint in relation to adverse events
timeFrame: Final post treatment visit
measure: Effectiveness endpoint gauged by reduction in fat layer thickness
timeFrame: Final post-treatment visit
Secondary outcomes:
measure: Subject survey
timeFrame: Final post-treatment visit
measure: Photo review
timeFrame: Final post-treatment visit
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Innovation Research Center
state: California
city: Sacramento
country: United States
facility: Laser & Skin Surgery Center of Northern California
state: California
city: Chestnut Hill
country: United States
facility: SkinCare Physicians of Chestnut Hill
state: Massachusetts
city: Edina
country: United States
facility: Zel Skin & Laser Specialist
state: Minnesota
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York
state: New York
city: Nashville
country: United States
facility: Brian S. Biesman, MD
state: Tennessee
city: Dallas
country: United States
facility: EpiCenter Skincare and Laser Center
state: Texas
Study officials:
affiliation: Zeltiq Aesthetics
name: Kerrie Jiang, NP
role: STUDY_DIRECTOR
References: