CoolSculpting System (ELI)

Zeltiq Aesthetics

Status

Completed

Conditions

Body Fat Disorder

Treatments

Device: The ZELTIQ System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04506307

ZA20-001

Details and patient eligibility

About

Evaluate the safety and efficacy of multiple, simultaneous CoolSculpting cycles for the purpose of non-invasive fat reduction.

Enrollment

35 patients

Sex

All

Ages

22 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Subject (healthy volunteer) has read and signed the study written informed consent form.
Male or female ≥ 22 years and ≤65 years of age.
Subject has clearly visible fat in one or more areas on the torso (abdomen, flank, back fat, bra fat), which in the investigator's opinion, may benefit from the treatment.
Subject has not had 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 study.
Subject has a BMI ≤ 30 as determined at screening.
Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.

Exclusion Criteria

Subject has had a recent surgical procedure 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, paroxysmal cold hemoglobinuria, or cold agglutinin disease.
Subject has a known sensitivity to cold, such as cold urticaria, Raynaud's disease, chilblains (pernio), 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 has a history of hernia in the area(s) to be treated.
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 is unable or unwilling to comply with the study requirements.
Subject is currently enrolled in a clinical study of any 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.