Body Fat Disorder
Conditions
Brief summary
Evaluate the safety and feasibility effecting the appearance of cellulite on the thigh using CoolSculpting.
Interventions
DEVICEThe ZELTIQ System
The CoolSculpting machine 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
FEMALE
Age
22 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Female subjects \> 22 years of age and \< 65 years of age. * Subject has clearly visible cellulite on the intended treatment area (thighs), which in the Investigator's opinion, may benefit from the treatment. * Subject has not had weight change exceeding 5% in the preceding month. * Subject agrees to maintain her weight (i.e., within 5%) by not making any major changes in diet or exercise routine 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, body contouring, cellulite reduction and/or skin tightening procedure in the area of intended treatment within the past 4 months. * Presence of significant suntan in the thighs. * Inability to avoid sun exposure in the thighs. * Subject has a history of hernia in or adjacent to the areas to be treated. * 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, cold agglutinin disease, 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 has known sensitivity or allergy to isopropyl alcohol and propylene glycol. * 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, implants (e.g. buttock implants), or drug delivery system. * Subject is pregnant or intending to become pregnant during the study period (in the next 9 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 |
|---|---|---|
| Percentage of Photographs Correctly Identified by Blinded Reviewers From the Independent Physician Reviewer Panel | Week 12 post final treatment (up to 24 weeks after first treatment) | Photographs of the treatment area taken at baseline and 12-weeks after final treatment were assessed for visual changes. Reported here is the mean percentage (%) of correct baseline identification of images by the blinded independent reviewers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) | Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment) | An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious AE was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An adverse devise effect (ADE) was any sign, symptom, or disease determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of a serious AE. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CoolSculpting of the Thigh Participants received up to 2 CoolSculpting treatments of the thigh performed at up to 6 weeks apart. | 97 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Pregnancy | 1 |
| Overall Study | Withdrawal by Subject | 14 |
Baseline characteristics
| Characteristic | CoolSculpting of the Thigh |
|---|---|
| Age, Continuous | 42.7 years STANDARD_DEVIATION 9.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaska Native | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 5 Participants |
| Race/Ethnicity, Customized Race Black or African American | 3 Participants |
| Race/Ethnicity, Customized Race Other | 6 Participants |
| Race/Ethnicity, Customized Race White | 82 Participants |
| Sex: Female, Male Female | 97 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 97 |
| other Total, other adverse events | 11 / 97 |
| serious Total, serious adverse events | 4 / 97 |
Outcome results
Primary
Percentage of Photographs Correctly Identified by Blinded Reviewers From the Independent Physician Reviewer Panel
Photographs of the treatment area taken at baseline and 12-weeks after final treatment were assessed for visual changes. Reported here is the mean percentage (%) of correct baseline identification of images by the blinded independent reviewers.
Time frame: Week 12 post final treatment (up to 24 weeks after first treatment)
Population: Per Protocol population consisted of all treated participants who 2 treatments, and weight change of no more than 5% of total body weight at the time the assessments were performed compared to the weight obtained at the first treatment visit. 'Overall number of participants analyzed' = participants evaluable for this endpoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CoolSculpting of the Thigh | Percentage of Photographs Correctly Identified by Blinded Reviewers From the Independent Physician Reviewer Panel | 55.7 % of images identified correctly |
Secondary
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)
An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious AE was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An adverse devise effect (ADE) was any sign, symptom, or disease determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of a serious AE.
Time frame: Baseline up to 36 weeks post final treatment (up to 42 weeks from first treatment)
Population: The Safety Population consisted of all enrolled participants who received at least 1 treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CoolSculpting of the Thigh | Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) | Device and/or Procedure Related AEs | 3 Participants |
| CoolSculpting of the Thigh | Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs) | SADEs | 0 Participants |