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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-02-28

Brief Summary

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

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Detailed Description

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

Conditions

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Body Fat Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Interventions

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The Zeltiq System

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

Intervention Type DEVICE

Other Intervention Names

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Cryolipolysis Lipolysis

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes