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Completed

NCT Number: NCT01579487

Extended Follow-Up Study for Subjects Who Participated in 2010 Study

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

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Key information

Conditions

Body Fat Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayoral Dermatology

Coral Gables, Florida, 33143, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The ZELTIQ System

Device

This is a follow-up study from the initial treatments performed in 2010. No additional treatments will be performed.

Other names: Cryolipolysis, Lipolysis

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Zeltiq Aesthetics

Industry

Registry information

Official study title

Non-Invasive Reduction of Abdominal Fat Utilizing the JUNO Applicator

Acronym: JUNO

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Apr 18, 2012
Registry last updated
Jun 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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