Body Fat Disorder
Conditions
Brief summary
Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a specialized surface applicator for non-invasive subcutaneous fat reduction in the upper arm.
Detailed description
This multi-center trial will evaluate the Zeltiq CoolSculpting treatment to perform treatments in the upper arm for the reduction subcutaneous fat reduction.
Interventions
DEVICECoolSculpting device with vacuum applicator.
The CoolSculpting device with a vacuum applicator will be used to perform the 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 sufficient for treatment on the upper arm, which in the investigator's opinion, may benefit from the treatment. * No weight change exceeding 5% in the preceding month. * 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 the study written informed consent form.
Exclusion criteria
* History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), or implants in or adjacent to the area of intended treatment. * History of prior surgery in the arms. * Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria. * Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. * History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. * History of carpal tunnel syndrome, compartment syndrome or deep vein thrombosis in the upper extremities. * Currently taking or has taken diet pills or weight control supplements within the past month. * Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation. * Active implanted device such as a pacemaker, defibrillator, or drug delivery system. * Pregnant or intending to become pregnant in the next 5 months. * Lactating or has been lactating in the past 6 months. * Unable or unwilling to comply with the study requirements. * 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 |
|---|---|---|
| Percentage of Pre-treatment Images Correctly Identified | 12 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. The review panel will consist of 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. Correct identification of photos by at least 2 of the 3 reviewers has an expected success rate of 75%. |
| Safety of the CoolSculpting Device in Upper Arm Treatments | 12 weeks post-treatment | The incidence of reported unanticipated adverse device effects (UADE) from the time of enrollment through the 12-week follow-up visit will be collected and analyzed. It is expected there will be zero UADE's reported. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Upper Arm Treatment With Vacuum Applicator The CoolSculpting device with vacuum applicator will be used to administer treatment. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Upper Arm Treatment With Vacuum Applicator |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Age, Continuous | 45.7 years |
| Body Mass Index | 28.2 kg//m^2 |
| Race/Ethnicity, Customized African American | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 24 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants |
| Race/Ethnicity, Customized Others | 5 Participants |
| Region of Enrollment Canada | 30 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 9 / 30 |
| serious Total, serious adverse events | 0 / 30 |
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. The review panel will consist of 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. Correct identification of photos by at least 2 of the 3 reviewers has an expected success rate of 75%.
Time frame: 12 weeks post treatment
Population: Thirty subjects received bilateral treatments to the upper arms. Three subjects did not maintain weight per-protocol requirements and were excluded from the primary efficacy analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Upper Arm Treatment With Vacuum Applicator | Percentage of Pre-treatment Images Correctly Identified | 85.2 percent correctly identified images |
95% CI: [72.9, 93.4]
Primary
Safety of the CoolSculpting Device in Upper Arm Treatments
The incidence of reported unanticipated adverse device effects (UADE) from the time of enrollment through the 12-week follow-up visit will be collected and analyzed. It is expected there will be zero UADE's reported.
Time frame: 12 weeks post-treatment
Population: The analysis population consisted of subjects to whom treatment was administered and who completed the 12 week post-treatment visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Upper Arm Treatment With Vacuum Applicator | Safety of the CoolSculpting Device in Upper Arm Treatments | 0 UADEs reported |