Pilot Study on The Flanks of Asian Patients | NCT01623037

NCT01623037

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

Label	Type	Description	Intervention Names
CoolSculpting Treatment Group	Experimental	The single arm will include all subjects treated on each flank with the CoolSculpting System and CoolCurve+ applicator. Treatment temperature and duration are defined in the protocol.	Device: The Zeltiq System

Name	Type	Description	Arm Group Labels	Other Names
The Zeltiq System	Device	Non-invasive cooling is applied to the each flank with a defined cooling rate and duration.	CoolSculpting Treatment Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion 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. Reviewers will be 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 and 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. Success is defined as 70% correct identification of pre-treatment images.	Baseline and 12 weeks post-final treatment
Safety of the CoolSculpting and the CoolCurve+ Applicator	The number of device- or procedure-related adverse events will be tabulated for all AEs reported continuously throughout the study, from enrollment to the final 12 week follow-up visit.	Enrollment through 12 weeks post-final treatment

Secondary Outcomes

Measure	Description	Time Frame
Subject Satisfaction With the Procedure	Subject satisfaction as assessed by questionnaire administered at 12-weeks post-treatment will be tabulated. The questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses. Subjects will be asked to determine overall satisfaction with the treatment. The choices will be: 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither unsatisfied nor satisfied; 4) somewhat satisfied; 5) very satisfied.

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Male or female subjects > 18 years of age.
Subjects must be of Asian descent.
Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
Subject has not had weight change exceeding 10 pounds in the preceding month.
Subject with body mass index (BMI) up to 25. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
Subject with sharp flank curvature that fits well with the CoolCurve+ applicator.
Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study.
Subject has read and signed a written informed consent form.

Exclusion Criteria

Subject has had a surgical procedure(s) in the area of intended treatment.
Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment.
Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
Subject has a known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin.
Subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
Subject is taking or has taken diet pills or supplements for weight loss within the past month.
Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).
Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
Subject is pregnant or intending to become pregnant during the study period (in the next 4 months).
Subject is lactating or has been lactating in the past 6 months.
Subject is unable or unwilling to comply with the study requirements.
Subject is 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.

Name	Affiliation	Role
Henry Chan, MD	Hong Kong Dermatology and Laser Centre	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hong Kong Dermatology and Laser Centre		Hong Kong	Hong Kong		China

ID	Title	Description
FG000	CoolSculpting Treatment Group	The single arm will include all subjects treated on the each flank with the CoolSculpting System and CoolCurve+ applicator. Treatment temperature and duration are defined in the protocol. The Zeltiq System: Non-invasive cooling is applied to the each flank with a defined cooling rate and duration.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	CoolSculpting Treatment Group	The single arm will include all subjects treated on the each flank with the CoolSculpting System and CoolCurve+ applicator. Treatment temperature and duration are defined in the protocol. The Zeltiq System: Non-invasive cooling is applied to the each flank with a defined cooling rate and duration.

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

Proportion 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. Reviewers will be 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 and 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. Success is defined as 70% correct identification of pre-treatment images.

All subjects in the analysis group were treated on each flank with CoolSculpting. Each subject had pre-treatment and post-treatment images taken.

Posted

Count of Units

photos

Baseline and 12 weeks post-final treatment

photos

ID	Title	Description

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	CoolSculpting Treatment Group	The single arm will include all subjects treated on the each flank with the CoolSculpting System and CoolCurve+ applicator. Treatment temperature and duration are defined in the protocol. The Zeltiq System: Non-invasive cooling is applied to the each flank with a defined cooling rate and duration.

ID	Term
D003357	Cosmetic Techniques
D013812	Therapeutics
D050110	Bariatric Surgery
D049088	Bariatrics