Effects on Cellulite Appearance | NCT04876118

NCT04876118

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
Fat Reduction	Experimental	The treatments are designed to see if the appearance of cellulite can be reduced on the outer thigh.	Device: The ZELTIQ System

Name	Type	Description	Arm Group Labels	Other Names
The ZELTIQ System	Device	The CoolSculpting machine will be used to perform the treatments.	Fat Reduction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Photographs Correctly Identified by Blinded Reviewers From the Independent Physician Reviewer Panel	Photographs of the treatment area taken at baseline and 12-weeks after final treatment were assessed for visual changes. Reported here is the mean percentage (%) of correct baseline identification of images by the blinded independent reviewers.	Week 12 post final treatment (up to 24 weeks after first treatment)

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Device and/or Procedure Related Adverse Events (AEs) and Device-related Serious Adverse Events (SADEs)	An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, whether or not considered related to treatment. A serious AE was an AE that resulted in death, serious deterioration in health, permanent impairment of a body structure/function, was life-threatening, required hospitalization or medical/surgical intervention, led to fetal distress or death, congenital abnormality, or birth defect. An adverse devise effect (ADE) was any sign, symptom, or disease determined by the Investigator to have a causal relationship or possible causal relationship with the investigational device, including any AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the device or from use error or intentional misuse of the device. A SADE was an ADE that resulted in any of the consequences characteristic of a serious AE.

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Female subjects > 22 years of age and < 65 years of age.
Subject has clearly visible cellulite on the intended treatment area (thighs), which in the Investigator's opinion, may benefit from the treatment.
Subject has not had weight change exceeding 5% in the preceding month.
Subject agrees to maintain her weight (i.e., within 5%) by not making any major changes in diet or exercise routine 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, body contouring, cellulite reduction and/or skin tightening procedure in the area of intended treatment within the past 4 months.
Presence of significant suntan in the thighs.
Inability to avoid sun exposure in the thighs.
Subject has a history of hernia in or adjacent to the areas to be treated.
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, cold agglutinin disease, 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 has known sensitivity or allergy to isopropyl alcohol and propylene glycol.
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, implants (e.g. buttock implants), or drug delivery system.
Subject is pregnant or intending to become pregnant during the study period (in the next 9 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
Study Director	Zeltiq Aesthetics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Investigate MD		Scottsdale	Arizona	85255	United States
Rebecca Fitzgerald, MD Dermatology

ID	Title	Description
FG000	CoolSculpting of the Thigh	Participants received up to 2 CoolSculpting treatments of the thigh performed at up to 6 weeks apart.

Baseline Characteristics Module

ID	Title	Description
BG000	CoolSculpting of the Thigh	Participants received up to 2 CoolSculpting treatments of the thigh performed at up to 6 weeks apart.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

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 Photographs Correctly Identified by Blinded Reviewers From the Independent Physician Reviewer Panel

Photographs of the treatment area taken at baseline and 12-weeks after final treatment were assessed for visual changes. Reported here is the mean percentage (%) of correct baseline identification of images by the blinded independent reviewers.

Per Protocol population consisted of all treated participants who 2 treatments, and weight change of no more than 5% of total body weight at the time the assessments were performed compared to the weight obtained at the first treatment visit. 'Overall number of participants analyzed' = participants evaluable for this endpoint.

Posted

Number

% of images identified correctly

Week 12 post final treatment (up to 24 weeks after first treatment)

ID	Title	Description
OG000	CoolSculpting of the Thigh	Participants received up to 2 CoolSculpting treatments of the thigh performed at up to 6 weeks apart.

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 of the Thigh	Participants received up to 2 CoolSculpting treatments of the thigh performed at up to 6 weeks apart.