Body Fat Disorder
Conditions
Brief summary
Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flank using an applicator with and without the Crown Cooling Insert.
Detailed description
This study will evaluate the Zeltiq CoolSculpting System when used with the standard CoolCore applicator and the CoolCore Applicator and the Crown Cooling Insert accessory.
Interventions
The CoolSculpting device and CoolCore applicator with and without the Crown Cooling Insert will be used to perform the treatments.
Sponsors
Zeltiq Aesthetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
Yes
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 5 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Correctly Identified Pre-treatment Photos by a Panel of Blinded Independent Reviewers | 12 weeks post-treatment | Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Success will be defined as at least 70% correct identification of the pre-treatment images for flanks treated with each treatment parameter by at least 2 of 3 reviewers. |
| Safety of the Zeltiq CoolSculpting System Using the CoolCore Applicator With and Without the Crown Cooling Insert | Enrollment through the 12 week post-treatment follow-up visit | The safety endpoint is the number of unanticipated adverse device effects (UADE) as well as the number of device and/or procedure-related adverse events. Adverse events are collected from the time of enrollment through the 12 week final follow-up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | 12 weeks post-treatment | Subject satisfaction as assessed by questionnaire administered at 12 weeks post-treatment. The questionnaire will consist of a 5-point Likert scale with the following selections options: 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither satisfied nor unsatisfied; 4) somewhat satisfied; 5) very satisfied. jIn addition, free-text fields provided options for subjects responses. |
Countries
United States
Participant flow
Recruitment details
Subjects seeking a reduction in fat in the flank area were recruited from the general population.
Participants by arm
| Arm | Count |
|---|---|
| CoolSculpting Treatment The ZELTIQ CoolSculpting System: The CoolSculpting device and CoolCore applicator will be used to perform the treatments. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | CoolSculpting Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 46.7 years |
| Body Mass Index | 25.3 kg/m^2 |
| Race/Ethnicity, Customized African American | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 16 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants |
| Race/Ethnicity, Customized Others | 0 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 |
| other Total, other adverse events | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
Percentage of Correctly Identified Pre-treatment Photos by a Panel of Blinded Independent Reviewers
Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Success will be defined as at least 70% correct identification of the pre-treatment images for flanks treated with each treatment parameter by at least 2 of 3 reviewers.
Time frame: 12 weeks post-treatment
Population: All subjects received bilateral flank treatments.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CoolSculpting Treatment With Standard CoolCore Applicator | Percentage of Correctly Identified Pre-treatment Photos by a Panel of Blinded Independent Reviewers | 16 photos |
| CoolSculpting Treatment/ CoolCore Applicator Plus CCI | Percentage of Correctly Identified Pre-treatment Photos by a Panel of Blinded Independent Reviewers | 15 photos |
95% CI: [60.4, 92.3]Catagorical tabulation
95% CI: [54.4, 93.9]
Primary
Safety of the Zeltiq CoolSculpting System Using the CoolCore Applicator With and Without the Crown Cooling Insert
The safety endpoint is the number of unanticipated adverse device effects (UADE) as well as the number of device and/or procedure-related adverse events. Adverse events are collected from the time of enrollment through the 12 week final follow-up visit.
Time frame: Enrollment through the 12 week post-treatment follow-up visit
Population: All 19 subjects were in the analysis group. Had there been any adverse events reported in the study period, each event would be categorized per intervention. However, there were zero adverse events reported for either of the two interventions and none reported for the study, therefore the arms were combined for the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CoolSculpting Treatment With Standard CoolCore Applicator | Safety of the Zeltiq CoolSculpting System Using the CoolCore Applicator With and Without the Crown Cooling Insert | 0 UADEs /device or procedure events |
Secondary
Subject Satisfaction
Subject satisfaction as assessed by questionnaire administered at 12 weeks post-treatment. The questionnaire will consist of a 5-point Likert scale with the following selections options: 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither satisfied nor unsatisfied; 4) somewhat satisfied; 5) very satisfied. jIn addition, free-text fields provided options for subjects responses.
Time frame: 12 weeks post-treatment
Population: The per-protocol population (19 subjects) was included in the analysis. Each subject received treatment on each flank; the standard CoolCore applicator was used on one flank and the contralateral flank was treated with the CoolCore with the Crown Cooling Insert.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CoolSculpting Treatment With Standard CoolCore Applicator | Subject Satisfaction | Treatment was comfortable to very comfortable | 11 Participants |
| CoolSculpting Treatment With Standard CoolCore Applicator | Subject Satisfaction | Very visible to somewhat visible fat reduction | 10 Participants |
| CoolSculpting Treatment With Standard CoolCore Applicator | Subject Satisfaction | Satisfied to very satisfied with procedure | 13 Participants |
| CoolSculpting Treatment/ CoolCore Applicator Plus CCI | Subject Satisfaction | Very visible to somewhat visible fat reduction | 10 Participants |
| CoolSculpting Treatment/ CoolCore Applicator Plus CCI | Subject Satisfaction | Treatment was comfortable to very comfortable | 12 Participants |
| CoolSculpting Treatment/ CoolCore Applicator Plus CCI | Subject Satisfaction | Satisfied to very satisfied with procedure | 12 Participants |