Body Fat Disorder
Conditions
Keywords
Lipolysis, Cryolipolysis, Fat Reduction
Brief summary
Evaluate the safety and feasibility of non-invasive fat reduction in the outer thigh with a belt applicator. Applicator design and treatment parameters will be evaluated.
Detailed description
The Zeltiq CoolSculpting System technology for cold-assisted lipolysis will be used with a modified belt applicator for the reduction of fat on the outer thigh. This is an open label, interventional, non-randomized feasibility study.
Interventions
DEVICEThe Zeltiq System with Modified Belt Applicator
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 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects \> 18 years of age and \< 65 years of age. * Subject has clearly visible fat on intended treatment area (outer thighs), which in the investigator's opinion, may benefit from the treatment(s). * 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 pounds) by not making any major changes in his/her diet or lifestyle 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 6 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 in the next 8 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 |
|---|---|---|
| Change in the Fat Layer of the Treated Area as Measured by Ultrasound The Change in Fat Layer Thickness in the Treated Outer Thigh | Baseline to 16 weeks post-final treatment | For each subject, ultrasound measurements will be obtained from the treated area and the contralateral untreated control area. The change in fat layer thickness in the untreated control thigh between baseline and 16 weeks will be used to account for variation in subject body weight during the study. The fat layer thickness change in the treated area will be normalized by subtracting the change in the untreated control thigh to remove the influence of subject weight variations. The normalized value will be used to evaluate success. The result is considered the treatment effect, an absolute change, and is reported as a mean change for the study population in centimeters of fat layer reduction. |
| Safety of the Zeltiq System and Procedure | Study enrollment through 16 weeks post-treatment | The number of device- and/or procedure related adverse events will be tabulated. Adverse event reports are collected throughout the study from the time of enrollment through the final 16 week follow-up visit. Investigators will determine whether an adverse event has a relationship to the study device or procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Correct Identification of Pre-treatment Photos | Baseline and 16 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 of the treated areas. Reviewers will be 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 (pre-treatment) 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. |
| Percentage of Participants With Satisfaction on Questionnaire Questions | 16 weeks post-treatment | Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment. The questionnaire was composed of 5-point Likert scale questions, as well as free text responses. Each question offered five choices, ranging from very favorable, somewhat favorable, neutral/not sure, unfavorable and very unfavorable responses. |
Countries
United States
Participant flow
Recruitment details
Subjects with clearly visible fat in the treatment area (outer thigh) were recruited from two clinical research sites.
Pre-assignment details
Screening of all subjects was completed to ensure each subject met all inclusion criteria and none of the exclusion criteria. A brief medical history and exam was performed at the screening visit. All female subjects of child bearing potential were given a pregnancy test.
Participants by arm
| Arm | Count |
|---|---|
| Fat Reduction of the Lateral Thigh Treatment with the CoolSculpting System and a modified belt applicator will be performed; non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. Treatment will be applied to one (1) outer thigh.
The Zeltiq System with Modified Belt Applicator: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
Baseline characteristics
| Characteristic | Fat Reduction of the Lateral Thigh |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants |
| Age, Continuous | 43.2 years STANDARD_DEVIATION 12.1 |
| Body Mass Index | 25.3 kg/m^2 |
| Race/Ethnicity, Customized African American | 1 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 31 Participants |
| Race/Ethnicity, Customized Hispanic | 5 Participants |
| Race/Ethnicity, Customized Not specified | 1 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 | 7 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Change in the Fat Layer of the Treated Area as Measured by Ultrasound The Change in Fat Layer Thickness in the Treated Outer Thigh
For each subject, ultrasound measurements will be obtained from the treated area and the contralateral untreated control area. The change in fat layer thickness in the untreated control thigh between baseline and 16 weeks will be used to account for variation in subject body weight during the study. The fat layer thickness change in the treated area will be normalized by subtracting the change in the untreated control thigh to remove the influence of subject weight variations. The normalized value will be used to evaluate success. The result is considered the treatment effect, an absolute change, and is reported as a mean change for the study population in centimeters of fat layer reduction.
Time frame: Baseline to 16 weeks post-final treatment
Population: The per-protocol population included all treated subjects who completed all follow-up visits and who maintained their body weight as directed by the study protocol. Six (6) subjects out of the 37 who completed the study, were excluded from the ultrasound measurement analysis because they had weight change greater than 5 pounds.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fat Reduction of the Lateral Thigh | Change in the Fat Layer of the Treated Area as Measured by Ultrasound The Change in Fat Layer Thickness in the Treated Outer Thigh | -0.25 cm | Standard Deviation 0.23 |
Primary
Safety of the Zeltiq System and Procedure
The number of device- and/or procedure related adverse events will be tabulated. Adverse event reports are collected throughout the study from the time of enrollment through the final 16 week follow-up visit. Investigators will determine whether an adverse event has a relationship to the study device or procedure.
Time frame: Study enrollment through 16 weeks post-treatment
Population: The as-treated (safety) analysis population consists of all subjects treated in the study wherein a safety evaluation was completed. Three (3) subjects were lost to follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fat Reduction of the Lateral Thigh | Safety of the Zeltiq System and Procedure | 1 Device/procedure-related AE |
Secondary
Percentage of Participants With Satisfaction on Questionnaire Questions
Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment. The questionnaire was composed of 5-point Likert scale questions, as well as free text responses. Each question offered five choices, ranging from very favorable, somewhat favorable, neutral/not sure, unfavorable and very unfavorable responses.
Time frame: 16 weeks post-treatment
Population: Of the forty enrolled subjects, three (3) were lost to follow-up and satisfaction questionnaires were not obtained.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fat Reduction of the Lateral Thigh | Percentage of Participants With Satisfaction on Questionnaire Questions | Procedure very to somewhat comfortable | 75.7 Percent of subjects expressing satis fac |
| Fat Reduction of the Lateral Thigh | Percentage of Participants With Satisfaction on Questionnaire Questions | Very visible to somewhat visible fat reduction | 86.5 Percent of subjects expressing satis fac |
| Fat Reduction of the Lateral Thigh | Percentage of Participants With Satisfaction on Questionnaire Questions | Positive overall effect | 70.3 Percent of subjects expressing satis fac |
| Fat Reduction of the Lateral Thigh | Percentage of Participants With Satisfaction on Questionnaire Questions | Very to somewhat satisfied with procedure | 86.5 Percent of subjects expressing satis fac |
| Fat Reduction of the Lateral Thigh | Percentage of Participants With Satisfaction on Questionnaire Questions | Somewhat to very different fit of clothing | 51.4 Percent of subjects expressing satis fac |
| Fat Reduction of the Lateral Thigh | Percentage of Participants With Satisfaction on Questionnaire Questions | Very likely to somewhat likely to have another tx | 97.3 Percent of subjects expressing satis fac |
| Fat Reduction of the Lateral Thigh | Percentage of Participants With Satisfaction on Questionnaire Questions | Very to somewhat likely to retreat the same area | 62.2 Percent of subjects expressing satis fac |
| Fat Reduction of the Lateral Thigh | Percentage of Participants With Satisfaction on Questionnaire Questions | Would recommend CoolSculpting to a friend | 89.19 Percent of subjects expressing satis fac |
Secondary
Percent of Correct Identification of 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 of the treated areas. Reviewers will be 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 (pre-treatment) 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.
Time frame: Baseline and 16 weeks post-final treatment
Population: Excluded from analysis are 6 subjects who did not maintain weight within protocol requirements and 3 subjects lost to follow-up.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Fat Reduction of the Lateral Thigh | Percent of Correct Identification of Pre-treatment Photos | 78 Photos |
95% CI: [74.8, 90.7]