CoolSculpting in the Abdomen Using Applicator With and Wi... | NCT02787850

NCT02787850

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
CoolSculpting Treatment Cohort A	Experimental	Cohort A will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 60 minutes using the CoolMax applicator without the Crown Cooling Insert. The contralateral side (Abdominal side 2) will be treated with the Crown Cooling Insert at a second protocol-defined temperature for 45 minutes. Each half of the abdominal area will be treated once, for a total of two treatments per subject.	Device: CoolSculpting Treatment
CoolSculpting Treatment Cohort B	Active Comparator	Cohort B will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 45 minutes using the CoolMax applicator with the Crown Cooling Insert. The contralateral side (Abdominal side 2) will be treated with a second protocol-defined temperature for 60 minutes with the Crown Cooling Insert. Each half of the abdominal area will be treated once, for a total of two treatments per subject.	Device: CoolSculpting Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CoolSculpting Treatment	Device	The CoolSculpting device will be used to perform treatments.	CoolSculpting Treatment Cohort A CoolSculpting Treatment Cohort B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Accurately Identified 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 photos for each subject photo series and record selections on a data collection form. Success is defined as at least 70% correct identification of pre-treatment images by two out of three reviewers.	12 weeks post treatment
Participants With Unanticipated Adverse Device Effects (UADE)	The number of unanticipated device effects will be tabulated to assess safety of the device and applicator accessory (Crown Cooling Insert). Adverse event data is collected from the time of enrollment through the 12 week follow-up visit.	Enrollment through 12 weeks post-treatment

Secondary Outcomes

Measure	Description	Time Frame
Subject Satisfaction Questionnaire	Subject satisfaction with the treatment experience data will also be collected via a written questionnaire at the 12-week follow up visits. This 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 satisfied; 2) somewhat satisfied; 3) neither satisfied nor unsatisfied; 4) somewhat unsatisfied; 5) very unsatisfied.

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Male or female subjects >22 years of age and < 65 years of age.
Subject has clearly visible fat on the abdomen, which in the investigator's opinion, may benefit from the treatment.
Subject is a candidate for a standard CoolSculpting treatment with a CoolMax applicator.
No weight change exceeding 5% of body weight in the preceding month.
Subject agrees to maintain his/her weight (i.e., within 5%) 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
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 12 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, 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 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 or any other metal containing implant.
Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).
Subject is lactating or has been lactating in the past 6 months.
Subject has a history of hernia in the areas to be treated.
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.
Subject is prone to severe claustrophobia (during MRI scans).
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
Leyda Bowes, MD	Bowes Dermatology Group	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Bowes Dermatology Group		Miami	Florida	33133	United States

Arm/Group Information

ID	Title	Description
FG000	CoolSculpting Treatment Cohort A	CoolSculpting device with and without Crown Cooling Insert and standard applicator and will be used to perform treatments on contralateral sides of the abdomen. Cohort A will receive treatments on one side of the abdomen without the Crown Cooling Insert with a protocol-defined temperature for 60 minutes. The contralateral side of the abdomen will be treated with the Crown Cooling Insert using a protocol-defined temperature for 45 minutes.
FG001	CoolSculpting Treatment Cohort B	CoolSculpting device with the Crown Cooling Insert and standard applicator and will be used to perform treatments on contralateral sides of the abdomen. Cohort B subjects will be treated one one half of the abdomen with the Crown Cooling Insert at a protocol-defined temperature for 45 minutes. The contralateral side of the abdomen will also be treated with the Cron Cooling Insert at a protocol-defined temperature for 60 minutes.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	CoolSculpting Treatment Cohort A	The treatments are designed to see if fat can be reduced in the abdomen with an applicator design incorporating a new insert. Treatment duration and cooling will vary between treatment sites and cohorts. The CoolSculpting device will be used to perform treatments.
BG001

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 Accurately Identified 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 photos for each subject photo series and record selections on a data collection form. Success is defined as at least 70% correct identification of pre-treatment images by two out of three reviewers.

The analysis population consisted of 19 subjects with evaluable images. Six images from each subject's abdomen were reviewed by the independent reviewers.

Posted

Count of Units

photos

12 weeks post 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	Cohort A-Abdomen Side 1	Cohort A will be treated on one side of the abdomen (Abdominal side 1) at a protocol-defined temperature for 60 minutes without the Crown Cooling Insert.