An interventional study of The ZELTIQ System in Body Fat Disorder, sponsored by Zeltiq Aesthetics. Completed at 1 site in Canada. Open to participants aged 22 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-23.
Sponsored by Zeltiq Aesthetics (part of AbbVie) · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the safety and efficacy of non-invasive reduction of subcutaneous fat along the jawline with Cryolipolysis.
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.
First submitted before Zeltiq Aesthetics became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The treatments are designed to see if the fat can be reduced along the jawline with Cryolipolysis.
Device: The ZELTIQ System
The CoolSculpting machine will be used to perform the treatments.
Number of Participants With Unanticipated Adverse Device Effects (UADE)
This outcome measurement considered all unanticipated device- or procedure-related adverse effects.
Time frame: Enrollment through study completion, an average of 6 months.
Number of Before and After Side-by-side Photograph Pairs Correctly Identified by At Least 2 of 3 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 (baseline) 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 photographs will be presented will be randomized; for each subject placement of the baseline and 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 75% correct identification of pre-treatment photos by 2 out of 3 reviewers.
Time frame: Baseline through 12 weeks post second treatment.
Change in Fat Layer in the Treated Jawline Area
When compared to baseline ultrasound imaging, the change in fat layer thickness at the final post-treatment visit will be measured. Ultrasound measurements were obtained in 5 areas intended for treatment at the baseline visit. A template was created for identification of the locations for subsequent measurements using external landmarks (e.g. skin imperfections) as reference points. The Treatment Effect = Follow-Up Average Thickness - Baseline Average Thickness. A negative change reflects a decrease in the average thickness from the baseline visit to the follow-up visit, and a positive result reflects an increase.
Time frame: Baseline and 12 weeks post-final treatment.
Overall Satisfaction With the Treatment
Subject satisfaction with the CoolSculpting procedure will be assessed by a questionnaire administered at the 12-week post-final treatment follow-up visit. The questionnaire will consist of 5-point Likert questions with 1 = very dissatisfied; 2 = dissatisfied; 3 = not sure; 4 = satisfied and 5 = very satisfied. Positive responses (very satisfied and satisfied) will be reported.
Time frame: 12-week post-final treatment follow-up visit
| Milestone | CoolSculpting for Jawline Contouring |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
This outcome measurement considered all unanticipated device- or procedure-related adverse effects.
| Participants with UADE reported | CoolSculpting for Jawline Contouring |
|---|---|
| Number of Participants With Unanticipated Adverse Device Effects (UADE) | 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 (baseline) 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 photographs will be presented will be randomized; for each subject placement of the baseline and 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 75% correct identification of pre-treatment photos by 2 out of 3 reviewers.
| Number Photo Pairs Correctly Identified | CoolSculpting for Jawline Contouring |
|---|---|
| Number of Before and After Side-by-side Photograph Pairs Correctly Identified by At Least 2 of 3 Blinded, Independent Reviewers | 8 |
When compared to baseline ultrasound imaging, the change in fat layer thickness at the final post-treatment visit will be measured. Ultrasound measurements were obtained in 5 areas intended for treatment at the baseline visit. A template was created for identification of the locations for subsequent measurements using external landmarks (e.g. skin imperfections) as reference points. The Treatment Effect = Follow-Up Average Thickness - Baseline Average Thickness. A negative change reflects a decrease in the average thickness from the baseline visit to the follow-up visit, and a positive result reflects an increase.
| cm | Submental Ultrasound Measurement | Submandibular Ultrasound Measurement (LEFT) | Submandibular Ultrasound Measurement (RIGHT) | Jowl Ultrasound Measurement (LEFT) | Jowl Ultrasound Measurement (RIGHT) |
|---|---|---|---|---|---|
| Change in Fat Layer in the Treated Jawline Area | -0.14 ± 0.12 | -0.10 ± 0.11 | -0.10 ± 0.11 | -0.08 ± 0.07 | -0.03 ± 0.05 |
Subject satisfaction with the CoolSculpting procedure will be assessed by a questionnaire administered at the 12-week post-final treatment follow-up visit. The questionnaire will consist of 5-point Likert questions with 1 = very dissatisfied; 2 = dissatisfied; 3 = not sure; 4 = satisfied and 5 = very satisfied. Positive responses (very satisfied and satisfied) will be reported.
| Participants | CoolSculpting for Jawline Contouring |
|---|---|
| Overall Satisfaction With the Treatment | 9 |
Collected over Adverse event data were collected from the time of enrollment through the final 12-week post-final treatment follow-up visit, an average of 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CoolSculpting for Jawline Contouring | 0/15 (0%) | 0/15 (0%) | 2/15 (13.3%) |
| Event | CoolSculpting for Jawline Contouring |
|---|---|
| Prolonged edemaSkin and subcutaneous tissue disorders | 2/15 |
| Prolonged bruisingSkin and subcutaneous tissue disorders | 1/15 |
| Age, Categorical(Participants) | CoolSculpting for Jawline Contouring |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 0 |
| Age, Continuous(years) | CoolSculpting for Jawline Contouring |
|---|---|
| Mean | 50.9 ± 7.6 |
| Sex: Female, Male(Participants) | CoolSculpting for Jawline Contouring |
|---|---|
| Female | 12 |
| Male | 3 |
| Race/Ethnicity, Customized(Participants) | CoolSculpting for Jawline Contouring |
|---|---|
| Am Indian or Alaska Native | 0 |
| Asian | 1 |
| Black or African American | 0 |
| Native Hawaiian or Other Pac Islander | 0 |
| White | 13 |
| Other | 1 |
| Region of Enrollment(participants) | CoolSculpting for Jawline Contouring |
|---|---|
| Canada | 15 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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