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Outer Thigh Study With Varied Treatment Parameters
NA trial testing The Zeltiq CoolSculpting System in Body Fat Disorder in 40 participants. Completed in 21 October 2014.
| Lead sponsor | Zeltiq Aesthetics |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 4 February 2014 |
| Primary completion | 21 October 2014 |
| Estimated completion | 21 October 2014 |
| Sites | 2 locations across United States |
Zeltiq Aesthetics — full company profile →
Adults 18 to 65, any sex, with Body Fat Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The number of device- or procedure-related adverse events will be tabulated from the time of enrollment through the 16 week follow-up visit.
| Group | Value | 95% CI |
|---|---|---|
| Lateral Thigh Treatment Parameter: -10C | 7 | |
| Contralateral Thigh Treatment Parameter: -13C | 4 | |
| Contralateral Thigh Treatment Parameter:-15C | 12 |
The number of unanticipated adverse device effects (UADEs) will be tabulated.
| Group | Value | 95% CI |
|---|---|---|
| Lateral Thigh Treatment Parameter: -10C | 0 | |
| Contralateral Thigh Treatment Parameter: -13C | 0 | |
| Contralateral Thigh Treatment Parameter:-15C | 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 ea
| Group | Value | 95% CI |
|---|---|---|
| All Subjects Both Outer Thighs | 168 | |
| Lateral Thigh Treatment Group-All Subjects | 79 | |
| Group 1: Contralateral Outer Thigh Treatment 2 | 38 | |
| Contralateral Outer Thigh Treatment Group 3 | 51 |
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, and in the adjacent untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control (untreated area) from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thicknes
| Group | Value | 95% CI |
|---|---|---|
| Group 1: All Subjects First Outer Thigh Treatment | -2.3 | ± 1.9 |
| Contralateral Thigh Treatment Group 2 | -1.3 | ± 1.5 |
| Contralateral Thigh Treatment Group 3 | -3.0 | ± 2.2 |
Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit. The questionnaire is composed of a 5-point Likert scale questions, as well as free text responses. Subjects will be asked to determine overall satisfaction with the treatment. The choices will be 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither unsatisfied or satisfied; 4) somewhat satisfied; 5) very satisfied.
| Group | Value | 95% CI |
|---|---|---|
| CoolSculpting of the Lateral Thigh Group | 22 |
| Group | Value | 95% CI |
|---|---|---|
| CoolSculpting of the Lateral Thigh Group | 25 |
| Group | Value | 95% CI |
|---|---|---|
| CoolSculpting of the Lateral Thigh Group | 36 |
| Group | Value | 95% CI |
|---|---|---|
| CoolSculpting of the Lateral Thigh Group | 28 |
| Group | Value | 95% CI |
|---|---|---|
| CoolSculpting of the Lateral Thigh Group | 32 |
Time frame: Adverse event data were collected from the time of enrollment through the 16-week follow-up visit, approximately 5 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Lateral Thigh Treatment Pa… | Contralateral Thigh Treatm… | Contralateral Thigh Treatm… |
|---|---|---|---|---|
| Prolonged sensory alteration post procedure | Skin and subcutaneous tissue disorders | — | — | — |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | — | — | — |
| Pain | General disorders | — | — | — |
| Sinus cold | General disorders | — | — | — |
| Surgical procedure | Musculoskeletal and connective tissue disorders | — | — | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Uterine fibroid | Reproductive system and breast disorders | — | — | — |
| Menstrual irregularity | Reproductive system and breast disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Bruising | Skin and subcutaneous tissue disorders | — | — | — |
| Lumbar cyst | Musculoskeletal and connective tissue disorders | — | — | — |
| Seasonal allergies | General disorders | — | — | — |
| Dry, flaky skin | Skin and subcutaneous tissue disorders | — | — | — |
Data from ClinicalTrials.gov NCT02081209 adverse events section.
The purpose of this study is to compare the performance of the Zeltiq CoolSculpting System using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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