Back to resultsExtended Follow-Up Study for Subjects Who Participated in 2010 Study (JUNO)
Primary Purpose
Body Fat Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Zeltiq System
Sponsored by
About this trial
This is an interventional other trial for Body Fat Disorder focused on measuring Lipolysis, Cryolipolysis, Fat Reduction
Eligibility Criteria
Inclusion Criteria:
- Subject participated in the ZA10-001 study, and received all study treatments.
- Subject has read and signed a written informed consent form.
Exclusion Criteria:
- Subject has had any surgical or aesthetic procedure(s) in or around the abdomen since the completion of the ZA10-001 study treatments.
- Subject is pregnant.
- Subject is unable or unwilling to comply with the study requirements.
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the integrity of the data.
Sites / Locations
- Mayoral Dermatology
Outcomes
Primary Outcome Measures
Independent Photo Review
The primary effectiveness endpoint is the correct identification of the series of pre-treatment images by the three reviewers.
Secondary Outcome Measures
Access reduction
Reduction in the fat layer thickness
Subject Satisfaction
Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the follow up visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01579487
Brief Title
Extended Follow-Up Study for Subjects Who Participated in 2010 Study
Acronym
JUNO
Official Title
Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeltiq Aesthetics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Fat Disorder
Keywords
Lipolysis, Cryolipolysis, Fat Reduction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
The Zeltiq System
Other Intervention Name(s)
Cryolipolysis, Lipolysis
Intervention Description
This is a follow-up study from the initial treatments performed in 2010. No additional treatments will be performed.
Primary Outcome Measure Information:
Title
Independent Photo Review
Description
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 Outcome Measure Information:
Title
Access reduction
Description
Reduction in the fat layer thickness
Time Frame
12+ mos post treatment
Title
Subject Satisfaction
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject participated in the ZA10-001 study, and received all study treatments.
Subject has read and signed a written informed consent form.
Exclusion Criteria:
Subject has had any surgical or aesthetic procedure(s) in or around the abdomen since the completion of the ZA10-001 study treatments.
Subject is pregnant.
Subject is unable or unwilling to comply with the study requirements.
Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the integrity of the data.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flor Mayoral, MD
Organizational Affiliation
Mayoral Dermatology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayoral Dermatology
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Extended Follow-Up Study for Subjects Who Participated in 2010 Study
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