Clinical trial NCT04506307: CoolSculpting System
Official title: Noninvasive Fat Reduction With the CoolSculpting System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Fat Disorder
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2020-08-10
Enrollment: 35
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 multiple, simultaneous CoolSculpting cycles for the purpose of non-invasive fat reduction.


Eligibility 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.

Primary outcomes:
measure: Percentage of Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer Panel
timeFrame: Week 12 post final treatment (18 weeks after first treatment)
Secondary outcomes:
measure: Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)
timeFrame: From first treatment up to Week 12 post final treatment (18 weeks after first treatment)
Other outcomes:
Locations:
city: Marina Del Rey
country: United States
facility: Marina Plastic Surgery
state: California
city: Pleasanton
country: United States
facility: Leyda E Bowes MD
state: California
city: Vista
country: United States
facility: Moradi MD Cosmetic Surgery
state: California
city: Miami
country: United States
facility: Riverchase Dermatology
state: Florida
Study officials:
affiliation: Zeltiq Aesthetics
name: Study Director
role: STUDY_DIRECTOR
References: