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

N/ACompletedNCT01579487

Zeltiq Aesthetics10 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Body Fat Disorder

Interventions

The Zeltiq SystemDEVICE

This is a follow-up study from the initial treatments performed in 2010. No additional treatments will be performed.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Mayoral Dermatology

Coral Gables, Florida, United States

Outcomes

Primary Outcomes

Independent Photo Review

The primary effectiveness endpoint is the correct identification of the series of pre-treatment images by the three reviewers.

Time frame: 12+ mos post treatment

Secondary Outcomes

Access reduction

Reduction in the fat layer thickness

Time frame: 12+ mos post treatment

Subject Satisfaction

Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the follow up visit.

Time frame: 12+ mos post treatment

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.