Body Fat Disorder
Conditions
Keywords
Lipolysis, Cryolipolysis, Fat Reduction
Brief summary
Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the outcome of non-invasive fat reduction using the ZELTIQ System.
Interventions
DEVICEThe Zeltiq System
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
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female subjects \> 18 years of age and \< 65 years of age. 2. Subject has clearly visible fat on intended treatment area, which in the investigator's opinion, may benefit from the treatment(s). 3. Subject has not had weight change exceeding 10 pounds in the preceding month. 4. Subject with body mass index (BMI) less than 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches. 5. Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study. 6. Subject has read and signed a written informed consent form.
Exclusion criteria
1. Subject presents a significant asymmetry of intended treatment areas. 2. Subject has had a surgical procedure(s) in the area of intended treatment in the past 5 years. 3. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment in the past 5 years. 4. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months. 5. 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. 6. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. 7. 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. 8. 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. 9. Subject is taking or has taken diet pills or weight control supplements within the past month. 10. 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). 11. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system. 12. Subject is pregnant or intending to become pregnant in the next 5 months. 13. Subject is lactating or has been lactating in the past 6 months. 14. Subject has a history of hernia in the areas to be treated. 15. Subject is unable or unwilling to comply with the study requirements. 16. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 17. 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 Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel | Baseline, Week 16 | Photographs of the treatment areas were taken at baseline, and at 16-weeks after the first treatment with the ZELTIQ System were assessed for any visual changes. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 16-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers. |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound | Baseline, Week 16 |
Countries
United States
Participant flow
Pre-assignment details
All participants who consented to participate in the study underwent a screening period of 90 days.
Participants by arm
| Arm | Count |
|---|---|
| The ZELTIQ System Participants received cryolipolysis treatment in the abdomen area for fat layer reduction on Day 0. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | The ZELTIQ System |
|---|---|
| Age, Continuous | 41.4 years |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 18 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 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 | 11 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 5 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel
Photographs of the treatment areas were taken at baseline, and at 16-weeks after the first treatment with the ZELTIQ System were assessed for any visual changes. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 16-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers.
Time frame: Baseline, Week 16
Population: Per-protocol Population included all the treated participants followed for 16 weeks post-treatment with weight change of no more than five pounds at the Week 16 visit.~Here, 'Overall Number of Participants Analyzed' is the number of participants evaluable for this Endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| The ZELTIQ System | Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel | 30.8 % of images identified correctly |
Secondary
Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound
Time frame: Baseline, Week 16
Population: Per-protocol Population included all the treated participants followed for 16 weeks post-treatment with weight change of no more than five pounds at the Week 16 visit.~Here, 'Overall Number of Participants Analyzed' is the number of participants evaluable for this Endpoint.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| The ZELTIQ System | Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound | -0.14 centimeters (cm) | Standard Deviation 0.21 |