Extended Follow-Up Study for Subjects Who Participated in 2010 Study (JUNO)
This study has been completed.
Information provided by (Responsible Party):
First received: March 15, 2012
Last updated: February 4, 2013
Last verified: March 2012
This study is being performed to follow up on subjects who participated in the initial study (ZA10-001) in 2010.
Body Fat Disorder
Device: The Zeltiq System
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
||Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2012 (Final data collection date for primary outcome measure)
Device: The Zeltiq System
This is a follow-up study from the initial treatments performed in 2010. No additional treatments will be performed.
The primary objective of this investigation is to assess the durability of treatment outcomes with the ZELTIQ System.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subject participated in the ZA10-001 study, and received all study treatments.
- Subject has read and signed a written informed consent form.
- 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.
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
|Coral Gables, Florida, United States, 33143 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 15, 2012
||February 4, 2013
||United States: Institutional Review Board
Keywords provided by Zeltiq Aesthetics:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 21, 2014
Lipid Metabolism Disorders
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Central Nervous System Diseases
Nervous System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases