Non-Invasive Reduction of Fat in the Inner Thighs | NCT01517659

NCT01517659

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
Fat Reduction	Experimental	The Zeltiq CoolSculpting System will be used to treat subcutaneous fat on each inner thigh.	Device: The Zeltiq CoolSculpting System

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Pre-Treatment Images Correctly Identified by Reviewers	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 photos for each subject photo series and record selections on a data collection form. The expected success rate is at least 80% correct identification of pre-treatment images and the majority of physician reviewers (2 out 3) correctly identify 75% of the pre-treatment images.	16 weeks post-treatment
Safety of the CoolSculpting Device and/or Procedure	The number of device- or procedure related adverse events will be tabulated. Adverse event data are collected continuously throughout the study period from the time of enrollment through the 16 week follow-up visit. At the time of an AE report, each study investigator determines the relationship to the investigational device or the study procedure.	Enrollment through 16 weeks post-treatment

Secondary Outcomes

Measure	Description	Time Frame
Subject Satisfaction	Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment.	16 weeks post-treatment
Reduction in Fat Layer Thickness in the Treated Area as Measured by Ultrasound

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 the inner thighs and 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 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, 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 (e.g., heparin, insulin) into the area of intended treatment 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 a 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 intends 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
Suzanne Kilmer, MD	Laser and Skin Surgery Center of Northern California	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Laser & Skin Surgery Center of Northern California		Sacramento	California	95816	United States
Zel Skin and Laser Specialists

PubMed Identifier	Type	Citation	Retractions
25586980	Result	Zelickson BD, Burns AJ, Kilmer SL. Cryolipolysis for safe and effective inner thigh fat reduction. Lasers Surg Med. 2015 Feb;47(2):120-7. doi: 10.1002/lsm.22320. Epub 2015 Jan 13.

ID	Title	Description
FG000	Fat Reduction in Inner Thighs	The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Fat Reduction in Inner Thighs	The Zeltiq CoolSculpting System: 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	Percentage of Pre-Treatment Images Correctly Identified by Reviewers	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 photos for each subject photo series and record selections on a data collection form. The expected success rate is at least 80% correct identification of pre-treatment images and the majority of physician reviewers (2 out 3) correctly identify 75% of the pre-treatment images.	The per protocol population included all subjects who completed follow-up visits and maintained weight within protocol-defined criteria. Pairs of subject photos (pre-treatment + post-treatment) were presented to blinded reviewers. Reviewers were blinded to time points of photos and the order of photo presentations was randomized.	Posted		Number	95% Confidence Interval	percentage of correct identifications		16 weeks post-treatment	photo pairs	photo pairs

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 in Inner Thighs	The Zeltiq CoolSculpting System: Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Adrenal gland mass	Endocrine disorders		Non-systematic Assessment	Mass documented 49 days post-treatment. Subsequent laparoscopic adrenalectomy performed. Not related to CoolSculpting procedure or device.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Numbness, persistent numbness	Skin and subcutaneous tissue disorders		Non-systematic Assessment	Mild numbness reported in treatment area. All mild numbness events resolved without medical intervention.

Title	Organization	Phone	Extension	Email
Kerrie Jiang, Executive Director, Regulatory, Clinical and Medical Affairs	Zeltiq Aesthetics	(925) 621-7462		kerrie.jiang@allergan.com

Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the untreated lateral thigh control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes will be normalized for each subject by subtracting the change in the control area from the change in treated area to remove the influence of weight variations. This result is considered the treatment effect. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated region as compared to the untreated control region. Results indicate the fat layer reduction in millimeters.