NCT04506307CompletedNot Applicable
Noninvasive Fat Reduction With the CoolSculpting System
Zeltiq Aesthetics8 sites in 1 country35 target enrollmentStarted: March 13, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 35
- Locations
- 8
- Primary Endpoint
- Percentage of Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer Panel
Study Overview
Brief Summary
Evaluate the safety and efficacy of multiple, simultaneous CoolSculpting cycles for the purpose of non-invasive fat reduction.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Percentage of Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer Panel
Time Frame: Week 12 post final treatment (18 weeks after first treatment)
Photographs of the treatment areas (torso) taken at baseline and 12-weeks after final treatment were assessed by blinded independent reviewers to determine if the CoolSculpting treatment had the effect of improvement in the reduction of fat. The reviewers were presented with 2 series of photographs the baseline and the post final treatment series, and asked to select the series representing the baseline photographs. The order in which the photographs were presented was randomized by participant. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers. Success was defined as at least 70% correct identification of the baseline images.
Secondary Outcomes
- Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)(From first treatment up to Week 12 post final treatment (18 weeks after first treatment))
Investigators
Study Sites (8)
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