Non-Invasive Reduction of Abdominal Fat (JUNO)

Zeltiq Aesthetics

Status

Completed

Conditions

Fat Reduction

Treatments

Device: The Zeltiq System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01101997

ZA10-001

Details and patient eligibility

About

This study is being performed to reduce unwanted abdominal fat using a new applicator for the Zeltiq System.

Full description

The primary objective of the study is to achieve a discernable change to the contour of the abdominal area treated with the JUNO applicator that is consistent with that documented during a clinical study of a previous applicator used to treat lovehandles.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female subjects > 18 years of age.
Subject has clearly visible fat on the abdomen.
Subject has not had weight change exceeding 10 pounds in the preceding month.
Subject agrees to maintain their weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
Subject has read and signed a written informed consent form.

Exclusion criteria

Subject has had a surgical procedure(s) in the area of intended treatment in the past 6 months.
Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment within the past year.
Subject has had a non-invasive fat reduction procedure in the area of intended treatment within the past 6 months.
Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
Subject has a known history of Reynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
Subject body mass index (BMI) exceeds 40. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
Subject is taking or has taken diet pills or supplements within the past month.
Subject has any dermatological conditions or scars in the location of the treatment sites that may interfere with the treatment or evaluation.
Subject is pregnant or intending to become pregnant in the next 6 months.
Subject is lactating or has been lactating in the past 6 months.
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 subject's response or the integrity of the data or would pose an unacceptable risk to the subject.