Body Fat Disorder
Conditions
Brief summary
Evaluate the safety and efficacy of abdominal DualSculpting with CoolAdvantage applicators.
Detailed description
The study will evaluate the safety and efficacy of non-invasive fat reduction in the abdomen using two applicators.
Interventions
DEVICEThe ZELTIQ System
The CoolSculpting System will be used to perform the treatments with the CoolAdvantage family of applicators.
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
1. Male or female subjects \>22 years of age and \< 65 years of age. 2. Subject who has been assessed to be eligible to receive multiple DualSculpting treatments on the abdomen using the CoolAdvantage and/or CoolAdvantage Plus applicator. 3. No weight change exceeding 5% of body weight in the preceding month. 4. 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. 5. Subject has read and signed the study written informed consent form.
Exclusion criteria
1. Subject has had a surgical procedure(s) in the area of intended treatmentSubject has had a surgical procedure(s) in the area of intended treatment. 2. Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment. 3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months. 4. 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. 5. Subject has a known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria. 6. 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. 7. 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. 8. Subject is taking or has taken diet pills or supplements within the past month. 9. 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). 10. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant. 11. Subject is pregnant or intending to become pregnant during the study period 12. Subject is lactating or has been lactating in the past 6 months. 13. Subject has a history of hernia in the areas to be treated. 14. Subject is unable or unwilling to comply with the study requirements. 15. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 16. 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 |
|---|---|---|
| Proportion of Correctly Identified Photos by Blinded Reviewers | Baseline to 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. 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. The primary efficacy endpoint of the study was the correct identification of baseline (pre-treatment) vs. 12 weeks post-final treatment images by two out of three blinded, independent reviewers. Success was defined as at least 70% correct identification of the baseline (pre-treatment) photographs. |
| Safety of the Zeltiq Device | 12 week post-treatment | The incidence of unanticipated adverse device effects will be measured. It is expected there will be zero UADEs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | 12 weeks post-treatment | Subject satisfaction with the Zeltiq procedure as determined by positive responses in a subject satisfaction questionnaire administered at the 12 weeks post-treatment visit. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses, with lower numbers (e.g. 1 or 2) indicating positive responses and higher numbers indicating less positive responses. |
Countries
United States
Participant flow
Pre-assignment details
Protocol defined inclusion and exclusion conditions determined study entry. All subjects were included in the single arm study.
Participants by arm
| Arm | Count |
|---|---|
| CoolSculpting of the Abdomen With Dual Applicators Non-invasive fat reduction of the abdomen was performed using the Zeltiq CoolSculpting System using dual applicators. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | CoolSculpting of the Abdomen With Dual Applicators |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 45.0 years STANDARD_DEVIATION 11 |
| Body Mass Index | 29.5 kg/m^2 |
| Race/Ethnicity, Customized African American | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 15 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Proportion of Correctly Identified Photos by Blinded 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. 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. The primary efficacy endpoint of the study was the correct identification of baseline (pre-treatment) vs. 12 weeks post-final treatment images by two out of three blinded, independent reviewers. Success was defined as at least 70% correct identification of the baseline (pre-treatment) photographs.
Time frame: Baseline to 12 weeks post-treatment
Population: Fourteen of 15 treated subjects were included in the per-protocol analysis. One subject was excluded from analysis due to a protocol-defined weight maintenance requirement. Pre-treatment and post-treatment photos were evaluated by 3 independent physician reviewers.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CoolSculpting of the Abdomen With Dual Applicators | Proportion of Correctly Identified Photos by Blinded Reviewers | 28 photos |
95% CI: [35.1, 87.2]
Primary
Safety of the Zeltiq Device
The incidence of unanticipated adverse device effects will be measured. It is expected there will be zero UADEs.
Time frame: 12 week post-treatment
Population: The as-treated population included all subjects who were treated with CoolSculpting.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CoolSculpting of the Abdomen With Dual Applicators | Safety of the Zeltiq Device | 0 device-or procedure-related AEs |
Secondary
Subject Satisfaction
Subject satisfaction with the Zeltiq procedure as determined by positive responses in a subject satisfaction questionnaire administered at the 12 weeks post-treatment visit. This questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses, with lower numbers (e.g. 1 or 2) indicating positive responses and higher numbers indicating less positive responses.
Time frame: 12 weeks post-treatment
Population: The per-protocol population consisted of 14 subjects. One subject was excluded for weight gain \>5%, a protocol defined limit for weight maintenance and was excluded from the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CoolSculpting of the Abdomen With Dual Applicators | Subject Satisfaction | Procedure comfortable/very comfortable | 7 Participants |
| CoolSculpting of the Abdomen With Dual Applicators | Subject Satisfaction | Feel appearance improved | 8 Participants |
| CoolSculpting of the Abdomen With Dual Applicators | Subject Satisfaction | Satisfied or very satisfied with procedure | 9 Participants |
| CoolSculpting of the Abdomen With Dual Applicators | Subject Satisfaction | Would recommend to a friend | 7 Participants |