Body Fat Disorder
Conditions
Brief summary
Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a small area applicator for non-invasive subcutaneous fat reduction in the distal thigh.
Detailed description
This study will investigate the use of a Small Area Applicator with the CoolSculpting device for reducing subcutaneous fat in the distal thigh. The study will evaluate the safety and effectiveness of treatments.
Interventions
DEVICEThe ZELTIQ System
The CoolSculpting System with a Small Area Applicator will be used to deliver treatments.
Sponsors
Zeltiq Aesthetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
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 distal thigh, 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 30. 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% of total body weight) 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 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 |
|---|---|---|
| Rate of Device- or Procedure-related Adverse Events | Study enrollment through 12-week final follow-up visit, approximately 15 weeks | The number of device- or procedure-related adverse events will be tabulated. Adverse event data are collected throughout the study period from the time of enrollment through the final follow-up visit. |
| Proportion of Correctly Identified Photos by Blinded Reviewers | 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. 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. Note: Due to the inconsistency of site photographic practices, the photos were not reasonably evaluable and therefore the independent phot review was not conducted. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment With Small Area Applicator Each enrolled subject was treated on a single thigh, in the distal region.
The ZELTIQ System: The CoolSculpting System with a Small Area Applicator will be used to deliver treatments. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Treatment With Small Area Applicator |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 44.6 years |
| Body Mass Index | 25.4 kg/m^2 |
| Race/Ethnicity, Customized African American | 1 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 28 Participants |
| Race/Ethnicity, Customized Hispanic | 9 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 |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 5 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Proportion of Correctly Identified Photos by Blinded 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. 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. Note: Due to the inconsistency of site photographic practices, the photos were not reasonably evaluable and therefore the independent phot review was not conducted.
Time frame: 12 weeks post final treatment
Population: Baseline and 12-week post-treatment photos were not reviewed by an independent panel of physicians due to inconsistencies of site photographic practices.
Primary
Rate of Device- or Procedure-related Adverse Events
The number of device- or procedure-related adverse events will be tabulated. Adverse event data are collected throughout the study period from the time of enrollment through the final follow-up visit.
Time frame: Study enrollment through 12-week final follow-up visit, approximately 15 weeks
Population: All subjects treated with the CoolSculpting System and the Small Area Applicator were assessed for device- or procedure-lated adverse events.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment With Small Area Applicator | Rate of Device- or Procedure-related Adverse Events | 1 device-or procedure-related AEs |