Clinical trial NCT02669329: CoolSculpting the Upper Arm Study
Official title: CoolSculpting the Upper Arm Using a Vacuum Applicator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Fat Disorder
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2016-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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

Eligibility 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.

Primary outcomes:
measure: Percentage of Pre-treatment Images Correctly Identified
timeFrame: 12 weeks post treatment
measure: Safety of the CoolSculpting Device in Upper Arm Treatments
timeFrame: 12 weeks post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Dr. Jean Carruthers Cosmetic Surgery Inc.
state: British Columbia
city: Vancouver
country: Canada
facility: Pacific Dermaesthetics
state: British Columbia
Study officials:
References:
citation: Carruthers JD, Humphrey S, Rivers JK. Cryolipolysis for Reduction of Arm Fat: Safety and Efficacy of a Prototype CoolCup Applicator With Flat Contour. Dermatol Surg. 2017 Jul;43(7):940-949. doi: 10.1097/DSS.0000000000001134.