Pilot Study on the Submental Area

Not Applicable

Completed

• Conditions: Body Fat Disorder

• Registration Number: NCT01859091
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

The purpose of this study is to evaluate the safety and feasibility of cryolipolysis for non-invasive reduction of submental fat.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-16
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-21
• Study Start: 2013-10-01
• Primary Completion: 2014-10
• Study Completion: 2014-10-01
• Results First Submitted: 2015-10-23
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-01
• Last Update Submitted: 2025-08-01
• Results First Posted: 2025-08-15
• Last Update Posted: 2025-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)	8-weeks post treatment	An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious adverse event (SAE) was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An ADE was any sign, symptom, or disease that was determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of an SAE.

Secondary Outcome Measures

Name	Time	Method
Change in the Fat Layer of the Treated Area as Measured by Ultrasound	Baseline, 8-weeks post treatment	Change in the fat layer thickness will be calculated by comparison of pre-treatment and 8-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 thickness for the treated region as compared to the untreated control. Results indicate the mean fat layer reduction in mm.
Number of Pre- and Post-Treatment Photograph Pair Reviews (Correctly Identified by an Internal Reviewer Panel of 4 Reviewers)	8-weeks post treatment	Photographs of the treatment areas taken at baseline and 8-weeks after final treatment were assessed for visible changes in contour in the treated areas. Pre- and post-treatment photograph pairs were randomized and reviewed by a blinded reviewer panel of 4 reviewers.

Trial Locations

Locations (1)

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