Body Fat Disorder
Conditions
Brief summary
Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the abdomen using an applicator with the Crown Cooling Insert.
Detailed description
Evaluation of CoolSculpting treatment in the abdomen using a vacuum applicator with an accessory insert.
Interventions
DEVICECoolSculpting Treatment
The CoolSculpting device will be used to perform treatments.
Sponsors
Zeltiq Aesthetics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
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 abdomen, which in the investigator's opinion, may benefit from the treatment. * Subject is a candidate for a standard CoolSculpting treatment with a CoolMax applicator. * No 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 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, cold agglutinin disease 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 or any other metal containing implant. * 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. * Subject is prone to severe claustrophobia (during MRI scans). * 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 Accurately Identified Pre-treatment Photos | 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 is defined as at least 70% correct identification of pre-treatment images by two out of three reviewers. |
| Participants With Unanticipated Adverse Device Effects (UADE) | Enrollment through 12 weeks post-treatment | The number of unanticipated device effects will be tabulated to assess safety of the device and applicator accessory (Crown Cooling Insert). Adverse event data is collected from the time of enrollment through the 12 week follow-up visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction Questionnaire | 12 weeks post-final treatment | Subject satisfaction with the treatment experience data will also be collected via a written questionnaire at the 12-week follow up visits. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses. Subjects will be asked to determine overall satisfaction with the treatment. The choices will be: 1) very satisfied; 2) somewhat satisfied; 3) neither satisfied nor unsatisfied; 4) somewhat unsatisfied; 5) very unsatisfied. |
Countries
United States
Participant flow
Recruitment details
Subjects seeking reduction of fat in the abdomen were recruited from the general population.
Participants by arm
| Arm | Count |
|---|---|
| CoolSculpting Treatment Cohort A The treatments are designed to see if fat can be reduced in the abdomen with an applicator design incorporating a new insert. Treatment duration and cooling will vary between treatment sites and cohorts.
The CoolSculpting device will be used to perform treatments. | 10 |
| CoolSculpting Treatment Cohort B The treatments are designed to see if fat can be reduced in the abdomen with an applicator design incorporating a new insert. Treatment duration and cooling will vary between treatment sites and cohorts.
The CoolSculpting device will be used to perform treatments. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | CoolSculpting Treatment Cohort A | CoolSculpting Treatment Cohort B | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 20 Participants |
| Age, Continuous | 44.4 years | 36.2 years | 40.3 years |
| Race/Ethnicity, Customized Hispanic or Latino | 10 Participants | 10 Participants | 20 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 14 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 1 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Participants With Unanticipated Adverse Device Effects (UADE)
The number of unanticipated device effects will be tabulated to assess safety of the device and applicator accessory (Crown Cooling Insert). Adverse event data is collected from the time of enrollment through the 12 week follow-up visit.
Time frame: Enrollment through 12 weeks post-treatment
Population: Subjects who received CoolSculpting treatment for reduction of subcutaneous fat in the abdomen were included in the analysis population. Of the 20 subjects enrolled and treated, one subject withdrew prior to study completion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study Population-Both Cohorts | Participants With Unanticipated Adverse Device Effects (UADE) | 0 UADEs |
| Abdomen Site Treated Using CCI for 60 Minutes and Warmer Temperature | Participants With Unanticipated Adverse Device Effects (UADE) | 0 UADEs |
Primary
Percentage of Accurately Identified Pre-treatment Photos
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 is defined as at least 70% correct identification of pre-treatment images by two out of three reviewers.
Time frame: 12 weeks post treatment
Population: The analysis population consisted of 19 subjects with evaluable images. Six images from each subject's abdomen were reviewed by the independent reviewers.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Overall Study Population-Both Cohorts | Percentage of Accurately Identified Pre-treatment Photos | 33 photos |
| Abdomen Site Treated Using CCI for 60 Minutes and Warmer Temperature | Percentage of Accurately Identified Pre-treatment Photos | 23 photos |
| Abdomen Sites Treated With CCI for 45 Minutes | Percentage of Accurately Identified Pre-treatment Photos | 50 photos |
| Abdomen Site Treated for 60 Minutes | Percentage of Accurately Identified Pre-treatment Photos | 23 photos |
95% CI: [71.9, 95.6]
95% CI: [57.7, 90.1]
95% CI: [76.3, 94.9]
95% CI: [66.3, 95.8]
Secondary
Subject Satisfaction Questionnaire
Subject satisfaction with the treatment experience data will also be collected via a written questionnaire at the 12-week follow up visits. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses. Subjects will be asked to determine overall satisfaction with the treatment. The choices will be: 1) very satisfied; 2) somewhat satisfied; 3) neither satisfied nor unsatisfied; 4) somewhat unsatisfied; 5) very unsatisfied.
Time frame: 12 weeks post-final treatment
Population: Groups include per-protocol subgroups for Cohort A and Cohort B. 20 subjects were assigned treatment parameters in Subgroup 2; one (1) subject withdrew from the study prior to completion.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall Study Population-Both Cohorts | Subject Satisfaction Questionnaire | Results expected or more than expected | 7 Participants |
| Overall Study Population-Both Cohorts | Subject Satisfaction Questionnaire | Very visible to visible fat reduction | 8 Participants |
| Overall Study Population-Both Cohorts | Subject Satisfaction Questionnaire | Satisfied to very satisfied with procedure | 9 Participants |
| Abdomen Site Treated Using CCI for 60 Minutes and Warmer Temperature | Subject Satisfaction Questionnaire | Results expected or more than expected | 14 Participants |
| Abdomen Site Treated Using CCI for 60 Minutes and Warmer Temperature | Subject Satisfaction Questionnaire | Very visible to visible fat reduction | 16 Participants |
| Abdomen Site Treated Using CCI for 60 Minutes and Warmer Temperature | Subject Satisfaction Questionnaire | Satisfied to very satisfied with procedure | 17 Participants |
| Abdomen Sites Treated With CCI for 45 Minutes | Subject Satisfaction Questionnaire | Very visible to visible fat reduction | 8 Participants |
| Abdomen Sites Treated With CCI for 45 Minutes | Subject Satisfaction Questionnaire | Satisfied to very satisfied with procedure | 7 Participants |
| Abdomen Sites Treated With CCI for 45 Minutes | Subject Satisfaction Questionnaire | Results expected or more than expected | 7 Participants |