Feasibility Study of a Belt Applicator

Not Applicable

Completed

• Conditions: Body Fat Disorder
• Interventions: Device: The Zeltiq System with Modified Belt Applicator

• Registration Number: NCT01767142
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

Evaluate the safety and feasibility of non-invasive fat reduction in the outer thigh with a belt applicator. Applicator design and treatment parameters will be evaluated.

Detailed Description

The Zeltiq CoolSculpting System technology for cold-assisted lipolysis will be used with a modified belt applicator for the reduction of fat on the outer thigh. This is an open label, interventional, non-randomized feasibility study.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-11
• Study First Posted: 2013-01-14
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2020-08-14
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-01
• Last Update Submitted: 2020-10-01
• Results First Posted: 2020-10-26
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Outer Thigh CoolSculpting Treatment	The Zeltiq System with Modified Belt Applicator	Treatment with the CoolSculpting System and a modified belt applicator will be performed on one outer thigh; the remaining thigh is considered the untreated control. Subjects will receive one cooling cycle applied to the thigh area intended for treatment with a protocol-defined cooling rate and duration of 120 minutes.

Primary Outcome Measures

Name	Time	Method
Change in the Fat Layer of the Treated Area as Measured by Ultrasound The Change in Fat Layer Thickness in the Treated Outer Thigh	Baseline to 16 weeks post-final treatment	For each subject, ultrasound measurements will be obtained from the treated area and the contralateral untreated control area. The change in fat layer thickness in the untreated control thigh between baseline and 16 weeks will be used to account for variation in subject body weight during the study. The fat layer thickness change in the treated area will be normalized by subtracting the change in the untreated control thigh to remove the influence of subject weight variations. The normalized value will be used to evaluate success. The result is considered the treatment effect, an absolute change, and is reported as a mean change for the study population in centimeters of fat layer reduction.
Safety of the Zeltiq System and Procedure	Study enrollment through 16 weeks post-treatment	The number of device- and/or procedure related adverse events will be tabulated. Adverse event reports are collected throughout the study from the time of enrollment through the final 16 week follow-up visit. Investigators will determine whether an adverse event has a relationship to the study device or procedure.

Secondary Outcome Measures

Name	Time	Method
Percent of Correct Identification of Pre-treatment Photos	Baseline and 16 weeks post-final 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 (pre-treatment) 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 Participants With Satisfaction on Questionnaire Questions	16 weeks post-treatment	Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment. The questionnaire was composed of 5-point Likert scale questions, as well as free text responses. Each question offered five choices, ranging from very favorable, somewhat favorable, neutral/not sure, unfavorable and very unfavorable responses.

Trial Locations

Locations (2)

Marina Plastic Surgery; 🇺🇸 Marina Del Rey, California, United States

Innovation Research Center; 🇺🇸 Pleasanton, California, United States