Body Fat Disorder
Conditions
Keywords
Lipolysis, Cryolipolysis, Fat Reduction
Brief summary
The purpose of this study is to evaluate the safety and efficacy of the ZELTIQ System and the CoolCurve+ applicator for non-invasive fat reduction in flanks for a patient population with sharp body curvature.
Detailed description
The Zeltiq System with the CoolCurve+ applicator will be evaluated for safety and effectiveness in subjects with subcutaneous fat on the flanks and who have sharp body curvatures. The curvature of interest is typical of individuals who are relatively thin with a small body frame.
Interventions
DEVICEThe Zeltiq System
Non-invasive 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 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects \> 18 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. * Subject has not had weight change exceeding 10 pounds in the preceding month. * Subject with body mass index (BMI) up to 29. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches. * Subject with sharp flank curvature that fits well with the CoolCurve+ applicator. * Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study. * Subject has read and signed a 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, abdominoplasty, 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 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 |
|---|---|---|
| Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature. | 8 weeks and 16 weeks post final treatment | Safety will be assessed by determination of the number of Unanticipated Adverse Device Effects (UADE) at the 8-week and 16-week post-treatment visits. |
| Change in Fat Layer Thickness When Compared to Untreated Control | 16 weeks post final treatment | 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 contralateral 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 the untreated control from the change in treated area to remove the influence of weight variations. Results indicate the mm of fat layer reduction in the treated area. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Pre-treatment Images Correctly Identified | 16 weeks post final 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. Results reflect the proportion of correctly identified images. |
| Subject Satisfaction Questionnaire | 16 weeks post final treatment | Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit. |
| Additional Safety Evaluation | Enrollment though 16 weeks post final treatment | The number of device or procedure-related adverse events will be evaluated. The investigator determines if the Zeltiq CoolSculpting System (device) or the treatment (procedure) are related to all reported adverse events. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zeltiq System Treatment Group All subjects treated with the Zeltiq System are included in the treatment arm.
The Zeltiq System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. | 25 |
| Total | 25 |
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 | 25 Participants |
| Age, Continuous | 37.9 years |
| Race/Ethnicity, Customized Asian | 13 Participants |
| Race/Ethnicity, Customized Caucasian | 9 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants |
| Race/Ethnicity, Customized Middle Eastern | 1 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 3 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Change in Fat Layer Thickness When Compared to Untreated Control
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 contralateral 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 the untreated control from the change in treated area to remove the influence of weight variations. Results indicate the mm of fat layer reduction in the treated area.
Time frame: 16 weeks post final treatment
Population: All subjects treated with the Zeltiq System were included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zeltiq System Treatment Group | Change in Fat Layer Thickness When Compared to Untreated Control | -1.3 mm | Standard Error 0.27 |
Primary
Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature.
Safety will be assessed by determination of the number of Unanticipated Adverse Device Effects (UADE) at the 8-week and 16-week post-treatment visits.
Time frame: 8 weeks and 16 weeks post final treatment
Population: All subjects treated with the Zeltiq System were included in the analysis population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zeltiq System Treatment Group | Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature. | UADE reported at 16 weeks | 0 UADEs |
| Zeltiq System Treatment Group | Safety of the Zeltiq System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature. | UADE reported at 8 weeks | 0 UADEs |
Secondary
Additional Safety Evaluation
The number of device or procedure-related adverse events will be evaluated. The investigator determines if the Zeltiq CoolSculpting System (device) or the treatment (procedure) are related to all reported adverse events.
Time frame: Enrollment though 16 weeks post final treatment
Population: All subjects treated with the Zeltiq System were included in the analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zeltiq System Treatment Group | Additional Safety Evaluation | 3 Device/ procedure-related AE's |
Secondary
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. Results reflect the proportion of correctly identified images.
Time frame: 16 weeks post final treatment
Population: All eligible subjects treated with the Zeltiq System and who maintained weight within protocol requirements were included in the analysis population. Paired photos of each subject were reviewed by 3 independent reviewers to properly identify pre-treatment images.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Zeltiq System Treatment Group | Proportion of Pre-treatment Images Correctly Identified | 54 photos |
95% CI: [0.614, 0.951]
Secondary
Subject Satisfaction Questionnaire
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 post final treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zeltiq System Treatment Group | Subject Satisfaction Questionnaire | Procedure was somewhat to very comfortable | 80 percentage of participants |
| Zeltiq System Treatment Group | Subject Satisfaction Questionnaire | Feel a difference in treated area | 36 percentage of participants |
| Zeltiq System Treatment Group | Subject Satisfaction Questionnaire | Somewhat to very visible fat reduction | 40 percentage of participants |
| Zeltiq System Treatment Group | Subject Satisfaction Questionnaire | Overall effect was more than or about was expected | 80 percentage of participants |
| Zeltiq System Treatment Group | Subject Satisfaction Questionnaire | Overall satisfaction with procedure | 92 percentage of participants |
| Zeltiq System Treatment Group | Subject Satisfaction Questionnaire | Would have area re-treated again | 88 percentage of participants |
| Zeltiq System Treatment Group | Subject Satisfaction Questionnaire | Would repeat procedure | 44 percentage of participants |
| Zeltiq System Treatment Group | Subject Satisfaction Questionnaire | Would have additional areas treated | 16 percentage of participants |
| Zeltiq System Treatment Group | Subject Satisfaction Questionnaire | Would recommend procedure to a friend | 100 percentage of participants |