An interventional study of The ZELTIQ CoolSculpting System in Body Fat Disorder, sponsored by Zeltiq Aesthetics. Completed at 1 site in United States. Open to participants aged 22 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-16.
Sponsored by Zeltiq Aesthetics · Not applicable, Interventional, and Treatment
The purpose of this study is to further evaluate the safety and efficacy of non-invasive reduction of subcutaneous fat in the submental and submandibular area using Cryolipolysis.
180 studies on the registry are indexed under Lipid Metabolism Disorders; 33 are open to participants now.
This study's enrollment of 14 is below the median of 51 across 136 interventional studies indexed under Lipid Metabolism Disorders.
Browse Lipid Metabolism Disorders studies →Zeltiq Aesthetics is the lead sponsor of 39 studies on the registry; none are open to participants now.
Of its 29 completed or terminated interventional studies of FDA-regulated products, 29 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
The treatments are designed to see if fat in the submandibular/submental area (chin), can be reduced using cryolipolysis.
Device: The ZELTIQ CoolSculpting System
The CoolSculpting device will be used to perform the treatments.
Proportion of Accurately Identified Pre-Treatment Photos by a Panel of Blinded Independent Reviewers
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 photos for each subject photo series and record selections on a data collection form. Success is defined as 70% correct identification of pre-treatment images by at least 70% correct identification of pre-treatment images by two out of three reviewers.
Time frame: Baseline (pre-treatment) and 12 weeks post treatment
The Number of Unanticipated Adverse Device Effects (UADE) Reported
The primary safety endpoint is the count of unanticipated adverse device effects (UADEs) reported in the study period. It is expected there will be zero UADEs.
Time frame: Enrollment through the 12 week final follow-up visit
Change in Fat Layer Thickness of the Submental Area as Measured by Caliper
Caliper measurements will be collected prior to treatment (pre-treatment) and at the 12-week follow-up visit. The caliper measurement process involves pinching the tissue within the treatment area in order to obtain the measurement, thereby folding the tissue and doubling the fat layer thickness. Measurements were taken with subjects standing in a neutral position. Measured values (mm) will be halved to reflect single fat layer change and will not take into account the fold of tissue during the measurement process. The fat layer measured pre-treatment will be compared to the 12-week post-treatment measurement.
Time frame: Baseline and 12 week post-treatment
Subject Satisfaction
Subject satisfaction as assessed by questionnaires administered at 12 weeks. Subjects will be asked to determine overall satisfaction with the treatment using a 5-point scale and free-text response options on a questionnaire. The choice options will be 1 = very dissatisfied, 2- dissatisfied, 3 - not sure, 4- satisfied and 5- very satisfied. Positive responses to questionnaire statements (score 4 or 5) will be used to assess satisfaction with the CoolSculpting procedure.
Time frame: 12 weeks post-treatment
Subjects seeking reduction of fat in the submental and submandibular area were recruited from the general population.
| Milestone | CoolSculpting With CoolMini Applicator for Fat Reduction in the Chin |
|---|---|
| Started | 14 |
| Completed | 14 |
| Not completed | 0 |
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 photos for each subject photo series and record selections on a data collection form. Success is defined as 70% correct identification of pre-treatment images by at least 70% correct identification of pre-treatment images by two out of three reviewers.
| photos | CoolSculpting With CoolMini Applicator |
|---|---|
| Proportion of Accurately Identified Pre-Treatment Photos by a Panel of Blinded Independent Reviewers | 11 |
The primary safety endpoint is the count of unanticipated adverse device effects (UADEs) reported in the study period. It is expected there will be zero UADEs.
| UADEs | CoolSculpting With CoolMini Applicator |
|---|---|
| The Number of Unanticipated Adverse Device Effects (UADE) Reported | 0 |
Caliper measurements will be collected prior to treatment (pre-treatment) and at the 12-week follow-up visit. The caliper measurement process involves pinching the tissue within the treatment area in order to obtain the measurement, thereby folding the tissue and doubling the fat layer thickness. Measurements were taken with subjects standing in a neutral position. Measured values (mm) will be halved to reflect single fat layer change and will not take into account the fold of tissue during the measurement process. The fat layer measured pre-treatment will be compared to the 12-week post-treatment measurement.
| millimeters fat layer change | CoolSculpting With CoolMini Applicator |
|---|---|
| Change in Fat Layer Thickness of the Submental Area as Measured by Caliper | -2.3 ± 0.8 |
Subject satisfaction as assessed by questionnaires administered at 12 weeks. Subjects will be asked to determine overall satisfaction with the treatment using a 5-point scale and free-text response options on a questionnaire. The choice options will be 1 = very dissatisfied, 2- dissatisfied, 3 - not sure, 4- satisfied and 5- very satisfied. Positive responses to questionnaire statements (score 4 or 5) will be used to assess satisfaction with the CoolSculpting procedure.
| Participants | CoolSculpting With CoolMini Applicator |
|---|---|
| Procedure comfortable/very comfortable | 7 |
| Visible fat/very visible fat reduction | 10 |
| Agree/strongly agree appearance more youthful | 9 |
| Agree/strongly agree chin looked more toned | 12 |
| Agree/strongly agree less self-conscious of chin | 11 |
| Agree/strongly agree appearance improved | 11 |
| Agree/strongly agree result was as expected | 11 |
| Satisfied/very satisfied with CoolSculpting | 13 |
| Would recommend procedure to a friend | 13 |
Collected over Adverse event data was collected from enrollment through the 12 week final follow-up visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CoolSculpting With CoolMini Applicator | 0/14 (0%) | 1/14 (7.1%) | 3/14 (21.4%) |
| Event | CoolSculpting With CoolMini Applicator |
|---|---|
| Hip ReplacementMusculoskeletal and connective tissue disorders | 1/14 |
| Event | CoolSculpting With CoolMini Applicator |
|---|---|
| Rash on face and neckSkin and subcutaneous tissue disorders | 1/14 |
| Ear painSurgical and medical procedures | 1/14 |
| Tongue tinglingGeneral disorders | 1/14 |
| Age, Categorical(Participants) | CoolSculpting With CoolMini Applicator |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 14 |
| >=65 years | 0 |
| Age, Continuous(years) | CoolSculpting With CoolMini Applicator |
|---|---|
| Mean | 50.5 (27 to 57) |
| Sex: Female, Male(Participants) | CoolSculpting With CoolMini Applicator |
|---|---|
| Female | 12 |
| Male | 2 |
| Race/Ethnicity, Customized(Participants) | CoolSculpting With CoolMini Applicator |
|---|---|
| African American | 2 |
| Asian | 0 |
| Caucasian | 12 |
| Hispanic | 0 |
| Other | 0 |
| Region of Enrollment(Participants) | CoolSculpting With CoolMini Applicator |
|---|---|
| United States | 14 |
| Body Mass Index(kg/m^2) | CoolSculpting With CoolMini Applicator |
|---|---|
| Mean | 33.1 (21.4 to 34.3) |
Plan to share: No
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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