CoolSculpting the Upper Arm Study (ARM)

Zeltiq Aesthetics

Status

Completed

Conditions

Body Fat Disorder

Treatments

Device: CoolSculpting device with vacuum applicator.

Study type

Interventional

Funder types

Industry

Identifiers

NCT02669329

ZA15-005

Details and patient eligibility

About

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.

Full description

This multi-center trial will evaluate the Zeltiq CoolSculpting treatment to perform treatments in the upper arm for the reduction subcutaneous fat reduction.

Enrollment

30 patients

Sex

All

Ages

22 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.