Reduction of Unwanted Fat
Conditions
Brief summary
The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Male or female subjects \> 18 years of age. 2. Subject has clearly visible fat on an area of the body appropriate for treatment with the non-invasive Zeltiq cooling device such as the flanks, thighs, abdomen or back. 3. Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month and plans to maintain their weight to within ±10 pounds over the next 6 months. 4. Subject has read and signed a written informed consent form.
Exclusion criteria
1. Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years. 2. Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months. 3. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. 4. Subject has used diet pills within the past 6 months. 5. Subject is unable or unwilling to comply with the study requirements. 6. Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation. 7. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 8. Patient is pregnant or intending to become pregnant in the next 9 months. 9. Patient is lactating or has been lactating in the past 9 months. 10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Visible Improvement in Treated Area | 4 months | Investigator assessment to document any visible improvement in the treatment area. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction | 4 months | Percentage satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Zeltiq Dermal Cooling Device: Non-invasive cooling was applied to the treatment area with a defined cooling rate and duration. | 175 |
| Total | 175 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Missed final study visit | 11 |
| Overall Study | No treatment (unable to attach sleeve to participant) | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 44.9 Years STANDARD_DEVIATION 11.3 |
| Sex: Female, Male Female | 132 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 175 |
| other Total, other adverse events | 12 / 175 |
| serious Total, serious adverse events | 0 / 175 |
Outcome results
Primary
Percentage of Participants With Visible Improvement in Treated Area
Investigator assessment to document any visible improvement in the treatment area.
Time frame: 4 months
Population: Participants with evaluable data for each body site were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Back Fat | Percentage of Participants With Visible Improvement in Treated Area | 65.2 percentage of participants |
| Love Handles | Percentage of Participants With Visible Improvement in Treated Area | 82.8 percentage of participants |
Secondary
Participant Satisfaction
Percentage satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire.
Time frame: 4 months
Population: Participants with evaluable data for each body site were included in this analysis. The row titled Percentage of participants 'Both Satisfied and Dissatisfied' on Subject Satisfaction Questionnaire was not applicable to the Love Handle treatment area, so no data were collected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Back Fat | Participant Satisfaction | Percentage of participants Neither Satisfied nor Dissatisfiedon Subject Satisfaction Questionnaire | 32.4 percentage of participants |
| Back Fat | Participant Satisfaction | Percentage of participants Dissatisfied on Subject Satisfaction Questionnaire | 8.1 percentage of participants |
| Back Fat | Participant Satisfaction | Percentage of participants Both Satisfied and Dissatisfied on Subject Satisfaction Questionnaire | 8.1 percentage of participants |
| Back Fat | Participant Satisfaction | Percentage of participants with overall satisfaction on Subject Satisfaction Questionnaire | 51.4 percentage of participants |
| Love Handles | Participant Satisfaction | Percentage of participants Dissatisfied on Subject Satisfaction Questionnaire | 6.2 percentage of participants |
| Love Handles | Participant Satisfaction | Percentage of participants with overall satisfaction on Subject Satisfaction Questionnaire | 58.5 percentage of participants |
| Love Handles | Participant Satisfaction | Percentage of participants Neither Satisfied nor Dissatisfiedon Subject Satisfaction Questionnaire | 35.4 percentage of participants |