Body Fat Disorder
Conditions
Keywords
Lipolysis, Cryolipolysis, Fat Reduction
Brief summary
The purpose of this study is to compare the performance of the Zeltiq CoolSculpting System using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.
Detailed description
The purpose of this study is to compare the performance of a cryolipolysis system using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.
Interventions
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
TREATMENT
Masking
NONE
Intervention model description
All subjects to be treated on one lateral thigh at a protocol-defined temperature for 120 minutes. Treatment of the contralateral thigh was performed using two unique protocol-defined temperatures for 60 minutes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female subjects \> 18 years of age and \< 65 years of age. 2. Subject has clearly visible fat on the intended treatment area (lateral thighs), which in the investigator's opinion, may benefit from the treatment. 3. Subject has not had weight change exceeding 10 pounds in the preceding month. 4. 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. 5. 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. 6. 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. 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 2 months. 4. Subject has significant asymmetry between the lateral thighs. 5. 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. 6. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. 7. 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. 8. 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. 9. Subject is taking or has taken diet pills or supplements within the past month. 10. 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). 11. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system 12. Subject is pregnant or intending to become pregnant during the study period (in the next 5 months). 13. Subject is lactating or has been lactating in the past 6 months. 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 |
|---|---|---|
| Safety of the Zeltiq Device | Time of enrollment though16 weeks post-treatment (approximately 5 months) | The number of device- or procedure-related adverse events will be tabulated from the time of enrollment through the 16 week follow-up visit. |
| Percentage of Pre-treatment Images Correctly Identified. | Baseline and 16 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. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 80%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Fat Layer of the Treated Area as Measured by Ultrasound | 16 weeks post-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 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 (untreated area) from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated region as compared to the untreated control. Results indicate the mean fat layer reduction in mm. |
| Subject Satisfaction | 16-weeks post treatment | Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit. The questionnaire is composed of a 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 unsatisfied; 2) somewhat unsatisfied; 3) neither unsatisfied or satisfied; 4) somewhat satisfied; 5) very satisfied. |
Countries
United States
Participant flow
Pre-assignment details
A total of 40 enrolled subjects, initiated treatment and had safety evaluations after treatment (safety population). The Per-Protocol Population included all treated subjects who completed treatment, were followed for 16 weeks and who did not become pregnant and with weight change of no more than 5 pounds at the time the final post-treatment images were taken.
Participants by arm
| Arm | Count |
|---|---|
| Lateral Thigh Treatment Group Non-invasive fat reduction of both lateral thighs was performed using the Zeltiq CoolSculpting System. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Lateral Thigh Treatment Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 43.0 years |
| Body Mass Index | 24.4 kg//m^2 |
| Race/Ethnicity, Customized African American | 1 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 31 Participants |
| Race/Ethnicity, Customized Hispanic | 5 Participants |
| Race/Ethnicity, Customized Others | 2 Participants |
| Region of Enrollment United States | 40 Participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 18 | 0 / 22 |
| other Total, other adverse events | 17 / 40 | 6 / 18 | 20 / 22 |
| serious Total, serious adverse events | 0 / 40 | 0 / 18 | 0 / 22 |
Outcome results
Primary
Percentage 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. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 80%.
Time frame: Baseline and 16 weeks post-treatment
Population: The per-protocol analysis population included subjects with available photos and complied with protocol-defined weight maintenance. Thirty-four subjects had 68 photo pairs which were presented to three blinded physician reviewers.Of the 37 subjects with available photos, 3 subjects were excluded due to weight change outside of protocol requirements.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Lateral Thigh Treatment Parameter: -10C | Percentage of Pre-treatment Images Correctly Identified. | 168 photos |
| Contralateral Thigh Treatment Parameter: -13C | Percentage of Pre-treatment Images Correctly Identified. | 79 photos |
| Contralateral Thigh Treatment Parameter:-15C | Percentage of Pre-treatment Images Correctly Identified. | 38 photos |
| Contralateral Outer Thigh Treatment Group 3 | Percentage of Pre-treatment Images Correctly Identified. | 51 photos |
95% CI: [76.4, 87.3]
95% CI: [68.1, 85.1]
95% CI: [65, 89.5]
95% CI: [84.6, 98.8]
Primary
Safety of the Zeltiq Device
The number of device- or procedure-related adverse events will be tabulated from the time of enrollment through the 16 week follow-up visit.
Time frame: Time of enrollment though16 weeks post-treatment (approximately 5 months)
Population: All subjects treated with the Zeltiq CoolSculpting System were included in the analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lateral Thigh Treatment Parameter: -10C | Safety of the Zeltiq Device | 7 device/procedure related AEs |
| Contralateral Thigh Treatment Parameter: -13C | Safety of the Zeltiq Device | 4 device/procedure related AEs |
| Contralateral Thigh Treatment Parameter:-15C | Safety of the Zeltiq Device | 12 device/procedure related AEs |
Primary
Safety of the Zeltiq Device
The number of unanticipated adverse device effects (UADEs) will be tabulated.
Time frame: From enrollment through 16 week follow-up (approximately 5 months)
Population: All subjects treated with the Zeltiq CoolSculpting System were included in the analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lateral Thigh Treatment Parameter: -10C | Safety of the Zeltiq Device | 0 UADEs reported |
| Contralateral Thigh Treatment Parameter: -13C | Safety of the Zeltiq Device | 0 UADEs reported |
| Contralateral Thigh Treatment Parameter:-15C | Safety of the Zeltiq Device | 0 UADEs reported |
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 (untreated area) from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated region as compared to the untreated control. Results indicate the mean fat layer reduction in mm.
Time frame: 16 weeks post-treatment
Population: The per-protocol analysis population included 33 subjects with available ultrasound images for both lateral thighs, resulting in 66 images for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lateral Thigh Treatment Parameter: -10C | Change in the Fat Layer of the Treated Area as Measured by Ultrasound | -2.3 mm | Standard Deviation 1.9 |
| Contralateral Thigh Treatment Parameter: -13C | Change in the Fat Layer of the Treated Area as Measured by Ultrasound | -1.3 mm | Standard Deviation 1.5 |
| Contralateral Thigh Treatment Parameter:-15C | Change in the Fat Layer of the Treated Area as Measured by Ultrasound | -3.0 mm | Standard Deviation 2.2 |
p-value: <0.001t-test, 2 sided
95% CI: [0.5, 2.1]
95% CI: [2, 4.1]
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. The questionnaire is composed of a 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 unsatisfied; 2) somewhat unsatisfied; 3) neither unsatisfied or satisfied; 4) somewhat satisfied; 5) very satisfied.
Time frame: 16-weeks post treatment
Population: Subjects completing the questionnaire at the 16-week follow-up visit were included in the analysis population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lateral Thigh Treatment Parameter: -10C | Subject Satisfaction | Procedure very to somewhat comfortable | 22 Participants |
| Lateral Thigh Treatment Parameter: -10C | Subject Satisfaction | Very to somewhat comfortable during weeks post procedure | 25 Participants |
| Lateral Thigh Treatment Parameter: -10C | Subject Satisfaction | Very visible to somewhat visible fat reduction | 36 Participants |
| Lateral Thigh Treatment Parameter: -10C | Subject Satisfaction | More than or about expected overall effect | 28 Participants |
| Lateral Thigh Treatment Parameter: -10C | Subject Satisfaction | Very to somewhat satisfied with procedure | 32 Participants |