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

Zeltiq Aesthetics

Status: Completed

Conditions: Body Fat Disorder

Treatments: Device: The Zeltiq System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01579487

ZA10-001.A1-EXT

Details and patient eligibility

About

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

Full description

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

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)