Back to resultsNon-invasive Cooling of Subcutaneous Fat
Primary Purpose
Fat Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Zeltiq Dermal Cooling Device
Sponsored by
About this trial
This is an interventional treatment trial for Fat Disorder
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects > 18 years of age.
- Subject has clearly visible fat on the flanks, thighs, abdomen, or back.
- Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month.
- Subject has read and signed a written informed consent form.
Exclusion Criteria:
- Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years.
- Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months.
- Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
- Subject is taking diet pills within the past 6 months.
- Subject is unable or unwilling to comply with the study requirements.
- Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.
- Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
- Patient is pregnant or intending to become pregnant in the next 9 months.
- Patient is lactating or has been lactating in the past 9 months.
- Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.
Sites / Locations
- Investigational Site
- Investigational Site
- Investigational Site
- Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Treatment Group 1
Treatment Group 2
Treatment Group 3
Treatment Group 4
Arm Description
Cooling Intensity Factor = 33 Duration = 60 minutes
Cooling Intensity Factor = 37 Duration = 30 minutes
Cooling Intensity Factor = 37 Duration = 45 minutes
Cooling Intensity Factor = 42 Cooling Duration = 30 minutes
Outcomes
Primary Outcome Measures
Change in Fat Layer Thickness of the Treated Flank
The change in fat layer thickness as demonstrated by measurement of fat layer layer thickness using ultrasound images taken in the treated area and on the contralateral flank (control) at baseline and at the 6 month follow-up. Data collected on the untreated side and the treated side will be combined to determine the normalized change in fat layer thickness for each subject. The mean percent fat layer reduction across all treatment groups will be presented, as well as for each treatment group.
Percentage of Subjects Expressing Satisfaction With the Procedure
Subject satisfaction as determined by the completion of a questionnaire at the 6 month follow-up visit, and, as requested, any other follow-up visits.
Percentage of Correctly Identified Pre-treatment Photographs
Change in the treated vs. untreated areas will be assessed for changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the control and treated flanks. Reviewers will be practicing dermatologists. All reviewers will be blinded to post-treatment vs. baseline and/or untreated flank. 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.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. Results reflect the percentage of correctly identified images.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00762307
Brief Title
Non-invasive Cooling of Subcutaneous Fat
Official Title
A Prospective, Multi-Center Clinical Study of Non-Invasive Cooling of Subcutaneous Fat
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zeltiq Aesthetics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.
Detailed Description
The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat using the Zeltiq Dermal Cooling device.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fat Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group 1
Arm Type
Experimental
Arm Description
Cooling Intensity Factor = 33 Duration = 60 minutes
Arm Title
Treatment Group 2
Arm Type
Experimental
Arm Description
Cooling Intensity Factor = 37 Duration = 30 minutes
Arm Title
Treatment Group 3
Arm Type
Experimental
Arm Description
Cooling Intensity Factor = 37 Duration = 45 minutes
Arm Title
Treatment Group 4
Arm Type
Experimental
Arm Description
Cooling Intensity Factor = 42 Cooling Duration = 30 minutes
Intervention Type
Device
Intervention Name(s)
Zeltiq Dermal Cooling Device
Intervention Description
Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
Primary Outcome Measure Information:
Title
Change in Fat Layer Thickness of the Treated Flank
Description
The change in fat layer thickness as demonstrated by measurement of fat layer layer thickness using ultrasound images taken in the treated area and on the contralateral flank (control) at baseline and at the 6 month follow-up. Data collected on the untreated side and the treated side will be combined to determine the normalized change in fat layer thickness for each subject. The mean percent fat layer reduction across all treatment groups will be presented, as well as for each treatment group.
Time Frame
Baseline and 6 months
Title
Percentage of Subjects Expressing Satisfaction With the Procedure
Description
Subject satisfaction as determined by the completion of a questionnaire at the 6 month follow-up visit, and, as requested, any other follow-up visits.
Time Frame
6 months post-treatment follow-up visit
Title
Percentage of Correctly Identified Pre-treatment Photographs
Description
Change in the treated vs. untreated areas will be assessed for changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the control and treated flanks. Reviewers will be practicing dermatologists. All reviewers will be blinded to post-treatment vs. baseline and/or untreated flank. 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.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. Results reflect the percentage of correctly identified images.
Time Frame
Baseline and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female subjects > 18 years of age.
Subject has clearly visible fat on the flanks, thighs, abdomen, or back.
Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month.
Subject has read and signed a written informed consent form.
Exclusion Criteria:
Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years.
Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months.
Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
Subject is taking diet pills within the past 6 months.
Subject is unable or unwilling to comply with the study requirements.
Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.
Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
Patient is pregnant or intending to become pregnant in the next 9 months.
Patient is lactating or has been lactating in the past 9 months.
Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerrie Jiang
Organizational Affiliation
Zeltiq Aesthetics
Official's Role
Study Chair
Facility Information:
Facility Name
Investigational Site
City
Dublin
State/Province
California
Country
United States
Facility Name
Investigational Site
City
Fremont
State/Province
California
Country
United States
Facility Name
Investigational Site
City
Pleasanton
State/Province
California
Country
United States
Facility Name
Investigational Site
City
San Ramon
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Non-invasive Cooling of Subcutaneous Fat
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