Body Fat Disorder
Conditions
Brief summary
Evaluate the performance of a cryolipolysis system using a colder treatment parameter for non-invasive reduction of subcutaneous fat in the lateral thighs.
Detailed description
Evaluation of the Zeltiq CoolSculpting System for non-invasive subcutaneous fat reduction in the lateral thighs.
Interventions
The CoolSculpting System delivers non-invasive cooling for the reduction of subcutaneous fat.
Sponsors
Zeltiq Aesthetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects \> 22 years of age and \< 65 years of age. * Subject has clearly visible fat on the intended treatment area (lateral thighs), 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 35. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches. * 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. * 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, 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 4 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 4 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 CoolSculpting System in the Outer Thighs | Enrollment through 12 week post-final treatment follow-up visit | Tabulation of device and/or procedure-related adverse events and unanticipated adverse device effects will be performed. Adverse event information will be collected from the time of study enrollment through the 12 week follow-up visit. The Investigator will determine if an adverse event is related to the device and/or study procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Correctly Identified Pre-treatment Photographs | 12 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. Success is defined as at least 70% correct identification of pre-treatment images by 2 out of 3 reviewers. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lateral Thigh Treatment Group Non-invasive subcutaneous fat reduction in the lateral thighs treatment group using the CoolSculpting System. | 19 |
| Total | 19 |
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 | 19 Participants |
| Age, Continuous | 45.0 years |
| Body Mass Index | 26.5 kg//m^2^ |
| Race/Ethnicity, Customized African American | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 16 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants |
| Race/Ethnicity, Customized Others | 1 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 14 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Safety of the Zeltiq CoolSculpting System in the Outer Thighs
Tabulation of device and/or procedure-related adverse events and unanticipated adverse device effects will be performed. Adverse event information will be collected from the time of study enrollment through the 12 week follow-up visit. The Investigator will determine if an adverse event is related to the device and/or study procedure.
Time frame: Enrollment through 12 week post-final treatment follow-up visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lateral Thigh Treatment Group | Safety of the Zeltiq CoolSculpting System in the Outer Thighs | Device and/or procedure related AEs | 8 events |
| Lateral Thigh Treatment Group | Safety of the Zeltiq CoolSculpting System in the Outer Thighs | UADEs reported | 0 events |
Secondary
Percentage of Correctly Identified Pre-treatment Photographs
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. Success is defined as at least 70% correct identification of pre-treatment images by 2 out of 3 reviewers.
Time frame: 12 weeks post-final treatment
Population: Photo pairs for 19 subjects were reviewed by blinded reviewers.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Lateral Thigh Treatment Group | Percentage of Correctly Identified Pre-treatment Photographs | 14 photo pairs |
95% CI: [48.8, 90.9]