CoolSculpting the Upper Arm Study
This trial is active, not recruiting.
|Condition||body fat disorder|
|Treatment||the zeltiq system|
|Start date||February 2016|
|End date||August 2016|
|Trial size||30 participants|
|Trial identifier||NCT02669329, ZA15-005|
Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a specialized surface applicator for non-invasive subcutaneous fat reduction in the upper arm.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
The treatments are designed to see if the fat, on the upper arm, can be reduced.
Blinded independent review of photographs to assess change in visible arm fat between baseline (pre-treatment) and 12 weeks post treatment.
time frame: 12 weeks post treatment
Male or female 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 sufficient for treatment on the upper arm, which in the investigator's opinion, may benefit from the treatment. - No weight change exceeding 5% in the preceding month. - 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 the study written informed consent form. Exclusion Criteria - History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), or implants in or adjacent to the area of intended treatment. - History of prior surgery in the arms. - Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease, or paroxysmal cold hemoglobinuria. - Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. - History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. - History of carpal tunnel syndrome, compartment syndrome or deep vein thrombosis in the upper extremities. - Currently taking or has taken diet pills or weight control supplements within the past month. - Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation. - Active implanted device such as a pacemaker, defibrillator, or drug delivery system. - Pregnant or intending to become pregnant in the next 5 months. - Lactating or has been lactating in the past 6 months. - Unable or unwilling to comply with the study requirements. - 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.
|Official title||CoolSculpting the Upper Arm Using a Vacuum Applicator|
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