Body Fat Disorder
Conditions
Keywords
Cryolipolysis, Fat Reduction
Brief summary
Evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the ZELTIQ CoolSculpting System.
Detailed description
The Zeltiq CoolSculpting System, which reduces subcutaneous fat in specific areas of the body, will be studied for safety and efficacy when used in the inner thigh.
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
Masking description
Panel of blinded physicians evaluated photos of pre-treatment and post-treatment images. Reviewers were blinded to the time point images were collected.
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 inner thighs and 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 his/her 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, abdominoplasty, 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 6 months. 4. Subject needs to administer, or has a known history of, subcutaneous injections (e.g., heparin, insulin) into the area of intended treatment 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 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 a 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 11. Subject is pregnant or intends to become pregnant in the next 8 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 |
|---|---|---|
| Percentage of Pre-Treatment Images Correctly Identified by Reviewers | 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. The expected success rate is at least 80% correct identification of pre-treatment images and the majority of physician reviewers (2 out 3) correctly identify 75% of the pre-treatment images. |
| Safety of the CoolSculpting Device and/or Procedure | Enrollment through 16 weeks post-treatment | The number of device- or procedure related adverse events will be tabulated. Adverse event data are collected continuously throughout the study period from the time of enrollment through the 16 week follow-up visit. At the time of an AE report, each study investigator determines the relationship to the investigational device or the study procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | 16 weeks post-treatment | Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment. |
| Reduction in Fat Layer Thickness in the Treated Area as Measured by Ultrasound | 16 week-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 untreated lateral thigh control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes will be normalized for each subject by subtracting the change in the control area from the change in treated area to remove the influence of weight variations. This result is considered the treatment effect. 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 region. Results indicate the fat layer reduction in millimeters. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fat Reduction in Inner Thighs The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Fat Reduction in Inner Thighs |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Age, Continuous | 48.1 years |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 41 Participants |
| Race/Ethnicity, Customized Hispanic | 2 Participants |
| Race/Ethnicity, Customized Others | 1 Participants |
| Region of Enrollment United States | 45 Participants |
| Sex: Female, Male Female | 45 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 12 / 45 |
| serious Total, serious adverse events | 2 / 45 |
Outcome results
Primary
Percentage of Pre-Treatment Images Correctly Identified by 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 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 at least 80% correct identification of pre-treatment images and the majority of physician reviewers (2 out 3) correctly identify 75% of the pre-treatment images.
Time frame: 16 weeks post-treatment
Population: The per protocol population included all subjects who completed follow-up visits and maintained weight within protocol-defined criteria. Pairs of subject photos (pre-treatment + post-treatment) were presented to blinded reviewers. Reviewers were blinded to time points of photos and the order of photo presentations was randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fat Reduction in Inner Thighs | Percentage of Pre-Treatment Images Correctly Identified by Reviewers | 90.5 percentage of correct identifications |
Primary
Safety of the CoolSculpting Device and/or Procedure
The number of device- or procedure related adverse events will be tabulated. Adverse event data are collected continuously throughout the study period from the time of enrollment through the 16 week follow-up visit. At the time of an AE report, each study investigator determines the relationship to the investigational device or the study procedure.
Time frame: Enrollment through 16 weeks post-treatment
Population: All subjects treated with CoolSculpting were included in the analysis group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fat Reduction in Inner Thighs | Safety of the CoolSculpting Device and/or Procedure | 14 device-or procedure-related AEs |
Secondary
Reduction in Fat Layer Thickness in 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 untreated lateral thigh control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes will be normalized for each subject by subtracting the change in the control area from the change in treated area to remove the influence of weight variations. This result is considered the treatment effect. 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 region. Results indicate the fat layer reduction in millimeters.
Time frame: 16 week-post-treatment
Population: Population includes all subjects with completed ultrasound images and who maintained weight within the protocol-defined weight requirement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fat Reduction in Inner Thighs | Reduction in Fat Layer Thickness in the Treated Area as Measured by Ultrasound | -2.8 mm | Standard Deviation 2.29 |
95% CI: [2.23, 3.27]
Secondary
Subject Satisfaction
Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment.
Time frame: 16 weeks post-treatment
Population: The analysis population included all subject responses collected at the 16 week follow-up visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fat Reduction in Inner Thighs | Subject Satisfaction | Very to somewhat satisfied w/ procedure and result | 42 Participants |
| Fat Reduction in Inner Thighs | Subject Satisfaction | Very visible to somewhat visible fat reduction | 38 Participants |
| Fat Reduction in Inner Thighs | Subject Satisfaction | Positive overall effect | 36 Participants |
| Fat Reduction in Inner Thighs | Subject Satisfaction | Very likely to somewhat likely to have another tx | 41 Participants |
| Fat Reduction in Inner Thighs | Subject Satisfaction | Would recommend CoolSculpting to friend | 40 Participants |