Fat Reduction
Conditions
Keywords
Lipolysis, Cryolipolysis, Fat Reduction
Brief summary
This study is being performed to reduce unwanted abdominal fat using a new applicator for the Zeltiq System.
Detailed description
The primary objective of the study is to achieve a discernable change to the contour of the abdominal area treated with the JUNO applicator that is consistent with that documented during a clinical study of a previous applicator used to treat lovehandles.
Interventions
DEVICEThe Zeltiq System
Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
Sponsors
Zeltiq Aesthetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female subjects \> 18 years of age. 2. Subject has clearly visible fat on the abdomen. 3. Subject has not had weight change exceeding 10 pounds in the preceding month. 4. Subject agrees to maintain their weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study. 5. Subject has read and signed a written informed consent form.
Exclusion criteria
1. Subject has had a surgical procedure(s) in the area of intended treatment in the past 6 months. 2. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year. 3. Subject has had a non-invasive fat reduction procedure in the area of intended treatment within the past 6 months. 4. Subject 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, or paroxysmal cold hemoglobinuria. 6. Subject has a known history of Reynaud'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 body mass index (BMI) exceeds 40. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches. 9. Subject is taking or has taken diet pills or supplements within the past month. 10. Subject has any dermatological conditions or scars in the location of the treatment sites that may interfere with the treatment or evaluation. 11. Subject is pregnant or intending to become pregnant in the next 6 months. 12. Subject is lactating or has been lactating in the past 6 months. 13. Subject is unable or unwilling to comply with the study requirements. 14. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 15. 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 Pre-treatment Images Correctly Identified | 16 weeks | 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. The expected success rate is an average 80% correct identification by the three reviewers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Fat Layer of the Treated Area as Measured by Ultrasound | 16 weeks | Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the adjacent untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control from the change in treated area to remove the influence of weight variations. Results indicate the fat layer reduction in mm. |
| Subject Satisfaction | 16 weeks | Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zeltiq System Treatment Group The treatment group consists of all subjects treated with the Zeltiq System for the reduction of abdominal fat. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Zeltiq System Treatment Group | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 60 Participants | — |
| Age, Continuous | 48.0 years STANDARD_DEVIATION 9.3 | — |
| Fitzpatrick Skin Type FST I-Always burns, never tans | 5 Participants | — |
| Fitzpatrick Skin Type FST II- Burns easily, tans poorlyy | 22 Participants | — |
| Fitzpatrick Skin Type FST III- Tans after initially burning | 21 Participants | — |
| Fitzpatrick Skin Type FST IV- Burns minimally, tans easily | 10 Participants | — |
| Fitzpatrick Skin Type FST VI- Never burns | 1 Participants | — |
| Fitzpatrick Skin Type FST V- Rarely burns, tans darkly easily | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 60 participants | — |
| Sex: Female, Male Female | 56 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 10 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Proportion of Pre-treatment Images Correctly Identified
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. The expected success rate is an average 80% correct identification by the three reviewers.
Time frame: 16 weeks
Population: The per protocol population are those subjects who were treated with the Zeltiq CoolSculping System and maintained weight as specified in the protocol.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Zeltiq System Treatment Group | Proportion of Pre-treatment Images Correctly Identified | 128 photos |
Comparison: H0: p= 0.6 and Ha: p ≠ 0.6p-value: <0.00195% CI: [0.773, 0.91]Chi-squared
Secondary
Change in the Fat Layer of the Treated Area as Measured by Ultrasound
Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the adjacent untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control from the change in treated area to remove the influence of weight variations. Results indicate the fat layer reduction in mm.
Time frame: 16 weeks
Population: All subjects who completed treatment with the Zeltiq System, independent of weight changes, were included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zeltiq System Treatment Group | Change in the Fat Layer of the Treated Area as Measured by Ultrasound | -1.9 mm | Standard Deviation 2.49 |
Secondary
Subject Satisfaction
Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit.
Time frame: 16 weeks
Population: All evaluable subjects that completed the satisfaction questionnaire were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zeltiq System Treatment Group | Subject Satisfaction | Would repeat the procedure | 62 percent of positive responses |
| Zeltiq System Treatment Group | Subject Satisfaction | Procedure somewhat uncomfortable to very comfortab | 88 percent of positive responses |
| Zeltiq System Treatment Group | Subject Satisfaction | Visible change in contour of treated region | 60 percent of positive responses |
| Zeltiq System Treatment Group | Subject Satisfaction | At least a slight difference in fit of clothes | 79 percent of positive responses |
| Zeltiq System Treatment Group | Subject Satisfaction | Overall effect was about, or more than expected | 50 percent of positive responses |
| Zeltiq System Treatment Group | Subject Satisfaction | Overall satisfaction with the procedure | 62 percent of positive responses |
| Zeltiq System Treatment Group | Subject Satisfaction | Would have the procedure on different body part | 65 percent of positive responses |
| Zeltiq System Treatment Group | Subject Satisfaction | Would recommend the procedure | 67 percent of positive responses |