Evaluate the safety and efficacy of multiple, simultaneous CoolSculpting cycles for the purpose of non-invasive fat reduction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
35
The CoolSculpting machine will be used to perform the treatments.
Marina Plastic Surgery
Marina del Rey, California, United States
Leyda E Bowes MD
Pleasanton, California, United States
Moradi MD Cosmetic Surgery
Vista, California, United States
Riverchase Dermatology
Miami, Florida, United States
Percentage of Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer Panel
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.
Time frame: Week 12 post final treatment (18 weeks after first treatment)
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE.
Time frame: From first treatment up to Week 12 post final treatment (18 weeks after first treatment)
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