Extended Follow-Up Study for Subjects Who Participated in 2010 Study

Not Applicable

Completed

• Conditions: Body Fat Disorder

• Registration Number: NCT01579487
• Lead Sponsor: Zeltiq Aesthetics

Brief Summary

This study is being performed to follow up on subjects who participated in the initial study (ZA10-001) in 2010.

Detailed Description

The primary objective of this investigation is to assess the durability of treatment outcomes with the ZELTIQ System.

Study Timeline

• Status Verified: 2012-03
• Study Start: 2012-03
• Study First Submitted: 2012-03-15
• Primary Completion: 2012-04
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-18
• Study Completion: 2013-02
• Last Update Submitted: 2017-06-20
• Last Update Posted: 2017-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Subject participated in the ZA10-001 study, and received all study treatments.
2. Subject has read and signed a written informed consent form.

Exclusion Criteria

1. Subject has had any surgical or aesthetic procedure(s) in or around the abdomen since the completion of the ZA10-001 study treatments.
2. Subject is pregnant.
3. Subject is unable or unwilling to comply with the study requirements.
4. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
5. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the integrity of the data.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Independent Photo Review	12+ mos post treatment	The primary effectiveness endpoint is the correct identification of the series of pre-treatment images by the three reviewers.

Secondary Outcome Measures

Name	Time	Method
Access reduction	12+ mos post treatment	Reduction in the fat layer thickness
Subject Satisfaction	12+ mos post treatment	Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the follow up visit.

Trial Locations

Locations (1)

Mayoral Dermatology; 🇺🇸 Coral Gables, Florida, United States