This trial is active, not recruiting.

Condition body fat disorder
Treatment the zeltiq system
Sponsor Zeltiq Aesthetics
Start date February 2014
End date November 2015
Trial size 45 participants
Trial identifier NCT02081209, ZA14-001


The purpose of this study is to compare the performance of a cryolipolysis system using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
the zeltiq system Cryolipolysis
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Primary Outcomes

Evaluate safety and efficacy of treatment
time frame: 16-weeks post treatment

Secondary Outcomes

Reduction measured by ultrasound
time frame: 16-weeks post treatment
Subject satisfaction
time frame: 16-weeks post treatment

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria 1. Male or female subjects > 18 years of age and < 65 years of age. 2. Subject has clearly visible fat on the intended treatment area (lateral thighs), which in the investigator's opinion, may benefit from the treatment. 3. Subject has not had weight change exceeding 10 pounds in the preceding month. 4. Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches. 5. Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study. 6. Subject has read and signed a written informed consent form. Exclusion Criteria 1. Subject has had a surgical procedure(s) in the area of intended treatment. 2. Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment. 3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 2 months. 4. Subject has significant asymmetry between the lateral thighs. 5. Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month. 6. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. 7. Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. 8. 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. 9. Subject is taking or has taken diet pills or supplements within the past month. 10. Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion). 11. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system 12. Subject is pregnant or intending to become pregnant during the study period (in the next 5 months). 13. Subject is lactating or has been lactating in the past 6 months. 14. Subject is unable or unwilling to comply with the study requirements. 15. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 16. 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.

Additional Information

Official title Non-Invasive Fat Layer Reduction in the Lateral Thighs With a Cryolipolysis System Using Varied Treatment Parameters
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Zeltiq Aesthetics.