CoolSculpting the Upper Arm Study | NCT02669329

NCT02669329

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Upper arm treatment with vacuum applicator	Experimental	Subjects with clearly visible fat sufficient for treatment received bilateral CoolSculpting treatments, 1 treatment on each arm.	Device: CoolSculpting device with vacuum applicator.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CoolSculpting device with vacuum applicator.	Device	The CoolSculpting device with a vacuum applicator will be used to perform the treatments.	Upper arm treatment with vacuum applicator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Pre-treatment Images Correctly Identified	Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. The review panel will consist of practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Correct identification of photos by at least 2 of the 3 reviewers has an expected success rate of 75%.	12 weeks post treatment
Safety of the CoolSculpting Device in Upper Arm Treatments	The incidence of reported unanticipated adverse device effects (UADE) from the time of enrollment through the 12-week follow-up visit will be collected and analyzed. It is expected there will be zero UADE's reported.	12 weeks post-treatment

Eligibility Module

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.

Facility	Status	City	State	ZIP	Country	Contacts
Dr. Jean Carruthers Cosmetic Surgery Inc.		Vancouver	British Columbia	V5Z 4E1	Canada
Pacific Dermaesthetics

PubMed Identifier	Type	Citation	Retractions
28595246	Result	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.

ID	Title	Description
FG000	Upper Arm Treatment Group	Each subject in the arm received bilateral treatment with the CoolSculpting device. Each arm was treated once.

Baseline Characteristics Module

ID	Title	Description
BG000	Upper Arm Treatment With Vacuum Applicator	The CoolSculpting device with vacuum applicator will be used to administer treatment.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Pre-treatment Images Correctly Identified

Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. The review panel will consist of practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Correct identification of photos by at least 2 of the 3 reviewers has an expected success rate of 75%.

Thirty subjects received bilateral treatments to the upper arms. Three subjects did not maintain weight per-protocol requirements and were excluded from the primary efficacy analysis.

Posted

Number

95% Confidence Interval

percent correctly identified images

12 weeks post treatment

photo pairs reviewed

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Upper Arm Treatment With Vacuum Applicator	The CoolSculpting device with vacuum applicator will be used to administer treatment.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Prolonged bilateral numbness	Nervous system disorders		Non-systematic Assessment	Four (4) subjects reported prolonged numbness. Bilateral numbness was documented for 3 of the 4 subjects; unilateral numbness was reported for 1 subject.