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
• Status Verified: 2013-10
• Study Start: 2013-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-16

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
Evaluate safety of treatment times	8-weeks post treatment	The primary objective of this study is to evaluate the safety of submental fat reduction with the ZELTIQ System. Safety is defined as incidence of device- and/or procedure-related adverse events.

Secondary Outcome Measures

Name	Time	Method
Reduction measured by ultrasound	8-weeks post treatment	Percent reduction in fat layer thickness in the treated areas, as measured by ultrasound, at 8 weeks post-treatment.
Photo Review	8-weeks post treatment	Comparison of pre- and 8-week post-treatment photographs to assess visible changes in contour in the treated areas.

Trial Locations

Locations (1)

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