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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics
ClinicalTrials.gov Identifier:
NCT01579487
First received: March 15, 2012
Last updated: February 4, 2013
Last verified: March 2012
  Purpose

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


Condition Intervention
Body Fat Disorder
Device: The Zeltiq System

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator

Resource links provided by NLM:


Further study details as provided by Zeltiq Aesthetics:

Primary Outcome Measures:
  • Independent Photo Review [ Time Frame: 12+ mos post treatment ] [ Designated as safety issue: No ]
    The primary effectiveness endpoint is the correct identification of the series of pre-treatment images by the three reviewers.


Secondary Outcome Measures:
  • Access reduction [ Time Frame: 12+ mos post treatment ] [ Designated as safety issue: No ]
    Reduction in the fat layer thickness

  • Subject Satisfaction [ Time Frame: 12+ mos post treatment ] [ Designated as safety issue: No ]
    Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the follow up visit.


Enrollment: 10
Study Start Date: March 2012
Study Completion Date: February 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
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
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579487

Locations
United States, Florida
Mayoral Dermatology
Coral Gables, Florida, United States, 33143
Sponsors and Collaborators
Zeltiq Aesthetics
  More Information

No publications provided

Responsible Party: Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT01579487     History of Changes
Other Study ID Numbers: ZA10-001.A1-EXT
Study First Received: March 15, 2012
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Zeltiq Aesthetics:
Lipolysis
Cryolipolysis
Fat Reduction

Additional relevant MeSH terms:
Sphingolipidoses
Lipid Metabolism Disorders
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on July 28, 2014