Extended Follow-Up Study for Subjects Who Participated in 2010 Study (JUNO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01579487
Recruitment Status : Completed
First Posted : April 18, 2012
Last Update Posted : June 22, 2017
Information provided by (Responsible Party):
Zeltiq Aesthetics

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

Condition or disease Intervention/treatment Phase
Body Fat Disorder Device: The Zeltiq System Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator
Study Start Date : March 2012
Actual Primary Completion Date : April 2012
Actual Study Completion Date : February 2013

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

Primary Outcome Measures :
  1. Independent Photo Review [ Time Frame: 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 :
  1. Access reduction [ Time Frame: 12+ mos post treatment ]
    Reduction in the fat layer thickness

  2. Subject Satisfaction [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01579487

United States, Florida
Mayoral Dermatology
Coral Gables, Florida, United States, 33143
Sponsors and Collaborators
Zeltiq Aesthetics
Principal Investigator: Flor Mayoral, MD Mayoral Dermatology

Responsible Party: Zeltiq Aesthetics Identifier: NCT01579487     History of Changes
Other Study ID Numbers: ZA10-001.A1-EXT
First Posted: April 18, 2012    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: March 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zeltiq Aesthetics:
Fat Reduction

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases