This trial has been completed.

Condition body fat disorder
Treatment the zeltiq system
Sponsor Zeltiq Aesthetics
Start date January 2015
End date November 2015
Trial size 40 participants
Trial identifier NCT02335749, ZA14-004


Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a small area applicator for non-invasive subcutaneous fat reduction in the distal thigh.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose other
Masking no masking
The treatments are designed to see if the fat, on the distal thigh, can be reduced.
the zeltiq system
The CoolSculpting machine will be used to perform the treatments.

Primary Outcomes

Efficacy of treatment (Success will be defined as at least 70% correct identification of the pre-treatment images)
time frame: 12 weeks post final treatment

Eligibility Criteria

All participants from 22 years up to 65 years old.

Inclusion Criteria: - Male or female subjects > 22 years of age and < 65 years of age. - Subject has clearly visible fat on the distal thigh, which in the investigator's opinion, may benefit from the treatment. - Subject has not had weight change exceeding 10 pounds in the preceding month. - 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. - Subject agrees to maintain his/her weight (i.e., within 5% of total body weight) by not making any major changes in their diet or exercise routine 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. - Subject has had an invasive fat reduction procedure (e.g., liposuction, mesotherapy) in the area of intended treatment. - Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months. - 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. - Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. - 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. - 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 is taking or has taken diet pills or supplements within the past month. - 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). - Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system - Subject is pregnant or intending to become pregnant during the study period (in the next 5 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.

Additional Information

Official title CoolSculpting the Distal Thigh
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Zeltiq Aesthetics.