NCT02554760: CCI

Bilateral; Flank Study With Crown Cooling Insert

Completed NA Results posted Last updated 26 October 2020

What this trial tests

NA trial testing The ZELTIQ CoolSculpting System in Body Fat Disorder in 19 participants. Completed in 17 December 2015.

Timeline

15 September 2015

Primary endpoint
17 December 2015

17 December 2015

Quick facts

Lead sponsor	Zeltiq Aesthetics
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	19
Start date	15 September 2015
Primary completion	17 December 2015
Estimated completion	17 December 2015
Sites	1 location across United States

Drugs / interventions tested

• The ZELTIQ CoolSculpting System

Conditions studied

• Body Fat Disorder — all drugs for Body Fat Disorder →

Sponsor

Zeltiq Aesthetics — full company profile →

Who can join

Adults 22 to 65, any sex, with Body Fat Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Correctly Identified Pre-treatment Photos by a Panel of Blinded Independent Reviewers Primary · 12 weeks post-treatment

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
CoolSculpting Treatment With Standard CoolCore Applicator	16
CoolSculpting Treatment/ CoolCore Applicator Plus CCI	15

Safety of the Zeltiq CoolSculpting System Using the CoolCore Applicator With and Without the Crown Cooling Insert Primary · Enrollment through the 12 week post-treatment follow-up visit

The safety endpoint is the number of unanticipated adverse device effects (UADE) as well as the number of device and/or procedure-related adverse events. Adverse events are collected from the time of enrollment through the 12 week final follow-up visit.

Group	Value	95% CI
CoolSculpting Treatment	0

Subject Satisfaction Secondary · 12 weeks post-treatment

Subject satisfaction as assessed by questionnaire administered at 12 weeks post-treatment. The questionnaire will consist of a 5-point Likert scale with the following selections options: 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither satisfied nor unsatisfied; 4) somewhat satisfied; 5) very satisfied. jIn addition, free-text fields provided options for subjects responses.

Treatment was comfortable to very comfortable

Group	Value	95% CI
Standard CoolCore Without CCI	11
Flank Treated With CoolCore + CCI	12

Very visible to somewhat visible fat reduction

Group	Value	95% CI
Standard CoolCore Without CCI	10
Flank Treated With CoolCore + CCI	10

Satisfied to very satisfied with procedure

Group	Value	95% CI
Standard CoolCore Without CCI	13
Flank Treated With CoolCore + CCI	12

Sponsor's own description

Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flank using an applicator with and without the Crown Cooling Insert.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.