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

Body Fat Disorder Clinical Trial

— JUNO  

Official title:

Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579487
• Other study ID #: ZA10-001.A1-EXT
• Status: Completed
• Phase: N/A
• First received: March 15, 2012
• Last updated: June 20, 2017
• Start date: March 2012
• Est. completion date: February 2013

Study information

• Verified date: March 2012
• Source: Zeltiq Aesthetics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Body Fat Disorder
• Lipid Metabolism Disorders

Intervention

Device:
• The Zeltiq System
This is a follow-up study from the initial treatments performed in 2010. No additional treatments will be performed.

Locations

Country	Name	City	State
United States	Mayoral Dermatology	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Zeltiq Aesthetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Independent Photo Review	The primary effectiveness endpoint is the correct identification of the series of pre-treatment images by the three reviewers.	12+ mos post treatment
Secondary	Access reduction	Reduction in the fat layer thickness	12+ mos post treatment
Secondary	Subject Satisfaction	Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the follow up visit.	12+ mos post treatment