Body Fat Disorder
Conditions
Brief summary
Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using specialized vacuum applicators for non-invasive subcutaneous fat reduction of the upper arms.
Detailed description
Subcutaneous fat reduction of the upper arms using 2 vacuum applicator types will be done concurrently, such that a subject will have an applicator placed on each arm simultaneously.
Interventions
The CoolSculpting device will be used to perform 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 |
|---|---|---|
| Proportion of Correctly Identified Pre-treatment Photos | 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. Reviewers are practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images are 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 70% correct identification by 2 out of 3 reviewers. |
| Number of Participants With Unanticipated Adverse Device Effects (UADE) Associated With the CoolSculpting System and Vacuum Applicators in the Upper Arms | Enrollment through12 weeks post-final treatment | The primary safety endpoint of the study is the incidence of unanticipated adverse device effects (UADE) reported in the study period. Investigators assessed each adverse event to determine if there was relationship to the study device or procedure. Adverse event data are collected from the time of study enrollment through the final follow-up visit at 12 weeks post-treatment. |
Countries
Canada
Participant flow
Recruitment details
Subjects seeking a reduction in upper arm fat were recruited from the general population.
Participants by arm
| Arm | Count |
|---|---|
| CoolSculpting Intervention Group Subjects treated with CoolSculpting System for Arm Fat | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | CoolSculpting Intervention Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 51.1 years |
| Body Mass Index (BMI) | 26.8 kg/m^2 |
| Fitzpatrick Skin Type FST I -always burns, never tans | 0 participants in skin type category |
| Fitzpatrick Skin Type FST II- burns easily, tans poorly | 9 participants in skin type category |
| Fitzpatrick Skin Type FST III- tans after initial burn | 4 participants in skin type category |
| Fitzpatrick Skin Type FST IV - burns minimally, tans easily | 0 participants in skin type category |
| Fitzpatrick Skin Type FST VI- never burns | 0 participants in skin type category |
| Fitzpatrick Skin Type FST V- rarely burns, tans darkly easily | 2 participants in skin type category |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment Canada | 15 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Number of Participants With Unanticipated Adverse Device Effects (UADE) Associated With the CoolSculpting System and Vacuum Applicators in the Upper Arms
The primary safety endpoint of the study is the incidence of unanticipated adverse device effects (UADE) reported in the study period. Investigators assessed each adverse event to determine if there was relationship to the study device or procedure. Adverse event data are collected from the time of study enrollment through the final follow-up visit at 12 weeks post-treatment.
Time frame: Enrollment through12 weeks post-final treatment
Population: Each adverse event occurring in the per-protocol population of 15 subjects was evaluated by investigators for any relationship to the study device or procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CoolSculpting Intervention Group | Number of Participants With Unanticipated Adverse Device Effects (UADE) Associated With the CoolSculpting System and Vacuum Applicators in the Upper Arms | 0 number of participants with UADE |
Primary
Proportion of Correctly Identified Pre-treatment Photos
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. Reviewers are practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images are 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 70% correct identification by 2 out of 3 reviewers.
Time frame: 12 weeks post-final treatment
Population: The analysis population included subjects with baseline and post-treatment photos.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| CoolSculpting Intervention Group | Proportion of Correctly Identified Pre-treatment Photos | 26 photos |
95% CI: [69.3, 96.2]