An interventional study of The Zeltiq System in Body Fat Disorder, sponsored by Zeltiq Aesthetics. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.
Sponsored by Zeltiq Aesthetics · Not applicable, Interventional, and Other
Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the outcome of non-invasive fat reduction using the ZELTIQ System.
180 studies on the registry are indexed under Lipid Metabolism Disorders; 33 are open to participants now.
This study's enrollment of 19 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
Device: The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Also known as: Cryolipolysis, Lipolysis
Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel
Photographs of the treatment areas were taken at baseline, and at 16-weeks after the first treatment with the ZELTIQ System were assessed for any visual changes. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 16-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers.
Time frame: Baseline, Week 16
Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound
Time frame: Baseline, Week 16
| Milestone | The ZELTIQ System |
|---|---|
| Started | 19 |
| Received at least 1 study treatment | 19 |
| Completed | 19 |
| Not completed | 0 |
Photographs of the treatment areas were taken at baseline, and at 16-weeks after the first treatment with the ZELTIQ System were assessed for any visual changes. The photographs were assessed by blinded independent reviewers (IPR) to correctly identify the 16-weeks post-treatment photographs from randomly placed side-by-side comparison of before and after photographs. Reported here is the percentage (%) of images that were correctly identified by at least 2 out of 3 blinded independent reviewers.
| % of images identified correctly | The ZELTIQ System |
|---|---|
| Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel | 30.8 (9.1 to 61.4) |
| centimeters (cm) | The ZELTIQ System |
|---|---|
| Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound | -0.14 ± 0.21 |
Collected over From date of first treatment up to Week 16. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| The ZELTIQ System | 0/19 (0%) | 0/19 (0%) | 5/19 (26.3%) |
| Event | The ZELTIQ System |
|---|---|
| NauseaGastrointestinal disorders | 3/19 |
| VomitingGastrointestinal disorders | 3/19 |
| ConstipationGastrointestinal disorders | 1/19 |
| DiarrheaGastrointestinal disorders | 1/19 |
| Stool impactionGastrointestinal disorders | 1/19 |
| Common Cold/Respiratory InfectionGeneral disorders | 1/19 |
| CoughGeneral disorders | 1/19 |
| Nasal congestionGeneral disorders | 1/19 |
| Sore throatGeneral disorders | 1/19 |
| Firmness or discrete nodules within the treatment areaMusculoskeletal and connective tissue disorders | 1/19 |
Safety Population included all participants who received the study treatment.
| Age, Continuous(years) | The ZELTIQ System |
|---|---|
| Median | 41.4 (27.2 to 56.0) |
| Sex: Female, Male(Participants) | The ZELTIQ System |
|---|---|
| Female | 12 |
| Male | 7 |
| Race (NIH/OMB)(Participants) | The ZELTIQ System |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 6 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 11 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Race/Ethnicity, Customized(Participants) | The ZELTIQ System |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 18 |
Plan to share: No
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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Zeltiq Aesthetics