Feasibility Study of a Belt Applicator | NCT01767142

NCT01767142

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Outer Thigh CoolSculpting Treatment	Experimental	Treatment with the CoolSculpting System and a modified belt applicator will be performed on one outer thigh; the remaining thigh is considered the untreated control. Subjects will receive one cooling cycle applied to the thigh area intended for treatment with a protocol-defined cooling rate and duration of 120 minutes.	Device: The Zeltiq System with Modified Belt Applicator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The Zeltiq System with Modified Belt Applicator	Device	Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.	Outer Thigh CoolSculpting Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in the Fat Layer of the Treated Area as Measured by Ultrasound The Change in Fat Layer Thickness in the Treated Outer Thigh	For each subject, ultrasound measurements will be obtained from the treated area and the contralateral untreated control area. The change in fat layer thickness in the untreated control thigh between baseline and 16 weeks will be used to account for variation in subject body weight during the study. The fat layer thickness change in the treated area will be normalized by subtracting the change in the untreated control thigh to remove the influence of subject weight variations. The normalized value will be used to evaluate success. The result is considered the treatment effect, an absolute change, and is reported as a mean change for the study population in centimeters of fat layer reduction.	Baseline to 16 weeks post-final treatment
Safety of the Zeltiq System and Procedure	The number of device- and/or procedure related adverse events will be tabulated. Adverse event reports are collected throughout the study from the time of enrollment through the final 16 week follow-up visit. Investigators will determine whether an adverse event has a relationship to the study device or procedure.	Study enrollment through 16 weeks post-treatment

Secondary Outcomes

Measure	Description	Time Frame
Percent of Correct Identification of Pre-treatment Photos	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, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline (pre-treatment) photos for each subject photo series and record selections on a data collection form. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure.

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Male or female subjects > 18 years of age and < 65 years of age.
Subject has clearly visible fat on intended treatment area (outer thighs), which in the investigator's opinion, may benefit from the treatment(s).
Subject has not had weight change exceeding 10 pounds in the preceding month.
Subject with body mass index (BMI) up to 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in his/her 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, 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 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 in the next 8 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
Eric Bachelor, MD	Innovation Research Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Marina Plastic Surgery		Marina del Rey	California	90292	United States
Innovation Research Center

Label	URL
Cryolipolysis Conformable-Surface Applicator for Nonsurgical Fat Reduction in Lateral Thighs	View source

ID	Title	Description
FG000	Lateral Thigh Treatment Group	Treatment with the CoolSculpting System and a modified belt applicator will be performed. Non-invasive cooling is applied to one outer thigh with a protocol-defined cooling rate and duration of 120 minutes. Only one cooling cycle will be performed per subject.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Fat Reduction of the Lateral Thigh	Treatment with the CoolSculpting System and a modified belt applicator will be performed; non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. Treatment will be applied to one (1) outer thigh. The Zeltiq System with Modified Belt Applicator: Non-invasive cooling is applied to the treatment area 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

Change in the Fat Layer of the Treated Area as Measured by Ultrasound The Change in Fat Layer Thickness in the Treated Outer Thigh

For each subject, ultrasound measurements will be obtained from the treated area and the contralateral untreated control area. The change in fat layer thickness in the untreated control thigh between baseline and 16 weeks will be used to account for variation in subject body weight during the study. The fat layer thickness change in the treated area will be normalized by subtracting the change in the untreated control thigh to remove the influence of subject weight variations. The normalized value will be used to evaluate success. The result is considered the treatment effect, an absolute change, and is reported as a mean change for the study population in centimeters of fat layer reduction.

The per-protocol population included all treated subjects who completed all follow-up visits and who maintained their body weight as directed by the study protocol. Six (6) subjects out of the 37 who completed the study, were excluded from the ultrasound measurement analysis because they had weight change greater than 5 pounds.

Posted

Mean

Standard Deviation

Baseline to 16 weeks post-final treatment

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	Fat Reduction of the Lateral Thigh	Treatment with the CoolSculpting System and a modified belt applicator will be performed; non-invasive cooling is applied to the treatment area with a defined cooling rate and duration. The Zeltiq System with Modified Belt Applicator: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.