Clinical trial NCT02939105: CoolSculpting Treatment in the Upper Arms
Official title: DualSculpting the Upper Arms Using Vacuum Applicators and a Customized Treatment Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Fat Disorder
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2016-10-19
Enrollment: 15
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 specialized vacuum applicators for non-invasive subcutaneous fat reduction of the upper arms.

Detailed description: Subcutaneous fat reduction of the upper arms using 2 vacuum applicator types will be done concurrently, such that a subject will have an applicator placed on each arm simultaneously.

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: Proportion of Correctly Identified Pre-treatment Photos
timeFrame: 12 weeks post-final treatment
measure: Number of Participants With Unanticipated Adverse Device Effects (UADE) Associated With the CoolSculpting System and Vacuum Applicators in the Upper Arms
timeFrame: Enrollment through12 weeks post-final treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Pacific Dermaesthetics
state: British Columbia
Study officials:
affiliation: Pacific Dermaesthetics
name: Jason Rivers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rivers JK, Ulmer M, Vestvik B, Santos S. A customized approach for arm fat reduction using cryolipolysis. Lasers Surg Med. 2018 Mar 22. doi: 10.1002/lsm.22811. Online ahead of print.