An interventional study of CoolSculpting System in Body Fat Disorder, sponsored by Zeltiq Aesthetics. Completed at 3 sites in United States. Open to participants aged 22 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-24.
Sponsored by Zeltiq Aesthetics · Not applicable, Interventional, and Other
Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area using Cryolipolysis.
Healthy adult men and women with submental skin fold thickness > 1cm who desire reduction of submental fat.
Non-invasive treatment for subcutaneous fat reduction in the submental area.
180 studies on the registry are indexed under Lipid Metabolism Disorders; 33 are open to participants now.
This study's enrollment of 60 is above 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 intervention is the CoolSculpting System.
Device: CoolSculpting System
Safety of CoolScupting in the Submental Area
Safety of the Zeltiq CoolSculpting device will be assessed by measuring the incidence of device- and/or procedure-related adverse events. Adverse event reports are collected from the time of enrollment through the 12 week follow-up visit.
Time frame: Time of enrollment through12 week post-final treatment follow-up
Percentage of Correct Identification of Pre-treatment Photographs
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. 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: 12 week post-final-treatment
Change in the Fat Layer of the Treated Area as Measured by Ultrasound
Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Results indicate the fat layer reduction in cm.
Time frame: 12 weeks post-final treatment
Subject Satisfaction With CoolScupting in the Submental Area
Subject satisfaction as assessed by questionnaires administered at 12 weeks post-final treatment. The questionnaire will ask the subject about their treatment experience and the efficacy of the treatment.
Time frame: 12 weeks post-final treatment
| Milestone | CoolSculpting Treatment |
|---|---|
| Started | 60 |
| Completed | 60 |
| Not completed | 0 |
Safety of the Zeltiq CoolSculpting device will be assessed by measuring the incidence of device- and/or procedure-related adverse events. Adverse event reports are collected from the time of enrollment through the 12 week follow-up visit.
| incidence of device- and/or procedure AE | CoolSculpting Treatment |
|---|---|
| Safety of CoolScupting in the Submental Area | 4 |
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. 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 correcty identified photos | CoolSculpting Treatment |
|---|---|
| Percentage of Correct Identification of Pre-treatment Photographs | 91.4 |
Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Results indicate the fat layer reduction in cm.
| cm fat layer reduction post-procedure | CoolSculpting Treatment |
|---|---|
| Change in the Fat Layer of the Treated Area as Measured by Ultrasound | -0.20 ± 0.19 |
Subject satisfaction as assessed by questionnaires administered at 12 weeks post-final treatment. The questionnaire will ask the subject about their treatment experience and the efficacy of the treatment.
| Participants | CoolSculpting Treatment |
|---|---|
| Visible/Very Visible Fat Reduction | 46 |
| Satisfied/VerySatisfied with CoolSculpting | 50 |
| Procedure was Very Comfortable/Comfortable | 45 |
| Strongly Agree/Agree Procedure made more youthful | 30 |
| Strongly Agree/Agree chin looked more toned | 45 |
| Strongly Agree/Agree appearance has improved | 46 |
| Effect from procedure More Than Expected/Expected | 40 |
| Would recommend procedure to a friend | 48 |
| Feel less self-conscious about chin fat | 43 |
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 Treatment | 0/60 (0%) | 2/60 (3.3%) | 15/60 (25%) |
| Event | CoolSculpting Treatment |
|---|---|
| Food poisoningGastrointestinal disorders | 1/60 |
| Skin CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/60 |
| Event | CoolSculpting Treatment |
|---|---|
| ColdGeneral disorders | 5/60 |
| Prolonged erythemaSkin and subcutaneous tissue disorders | 2/60 |
| Pinched nerveMusculoskeletal and connective tissue disorders | 1/60 |
| Upper respiratory infectionInfections and infestations | 1/60 |
| InfluenzaInfections and infestations | 1/60 |
| Broken fingerMusculoskeletal and connective tissue disorders | 1/60 |
| PneumoniaInfections and infestations | 1/60 |
| Torn meniscusMusculoskeletal and connective tissue disorders | 1/60 |
| HivesGeneral disorders | 1/60 |
| Urinary tract infectionInfections and infestations | 1/60 |
Subjects treated with CoolSculpting for subcutaneous fat reduction in the submental area
| Age, Categorical(Participants) | CoolSculpting Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 60 |
| >=65 years | 0 |
| Age, Continuous(years) | CoolSculpting Treatment |
|---|---|
| Mean | 49.3 (25 to 61) |
| Sex: Female, Male(Participants) | CoolSculpting Treatment |
|---|---|
| Female | 48 |
| Male | 12 |
| Ethnicity (NIH/OMB)(Participants) | CoolSculpting Treatment |
|---|---|
| Hispanic or Latino | 5 |
| Not Hispanic or Latino | 55 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | CoolSculpting Treatment |
|---|---|
| United States | 60 |
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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