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

June 20, 2017 updated by: Zeltiq Aesthetics

Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Coral Gables, Florida, United States, 33143
        • Mayoral Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12+ mos post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Access reduction
Time Frame: 12+ mos post treatment
Reduction in the fat layer thickness
12+ mos post treatment
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.
12+ mos post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeltiq Aesthetics

Investigators

  • Principal Investigator: Flor Mayoral, MD, Mayoral Dermatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 15, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (Estimate)

April 18, 2012

Study Record Updates

Last Update Posted (Actual)

June 22, 2017

Last Update Submitted That Met QC Criteria

June 20, 2017

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZA10-001.A1-EXT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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