Back to resultsFat Layer Reduction in the Lateral Thighs Using CoolSculpting
Primary Purpose
Body Fat Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Zeltiq CoolSculpting System
Sponsored by
About this trial
This is an interventional treatment trial for Body Fat Disorder
Eligibility Criteria
Inclusion Criteria:
- Male or female subjects > 22 years of age and < 65 years of age.
- Subject has clearly visible fat on the intended treatment area (lateral thighs), which 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 35. 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%) by not making any major changes in their 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 and/or body contouring procedure in the area of intended treatment within the past 4 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 during the study period (in the next 4 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.
Sites / Locations
- Innovation Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lateral Thigh Treatment Group
Arm Description
CoolSculpting treatment in the lateral thighs for non-invasive subcutaneous fat reduction.
Outcomes
Primary Outcome Measures
Safety of the Zeltiq CoolSculpting System in the Outer Thighs
Tabulation of device and/or procedure-related adverse events and unanticipated adverse device effects will be performed. Adverse event information will be collected from the time of study enrollment through the 12 week follow-up visit. The Investigator will determine if an adverse event is related to the device and/or study procedure.
Secondary Outcome Measures
Percentage of Correctly Identified Pre-treatment Photographs
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 2 out of 3 reviewers.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02324816
Brief Title
Fat Layer Reduction in the Lateral Thighs Using CoolSculpting
Official Title
Non-Invasive Fat Layer Reduction in the Lateral Thighs With a Cryolipolysis System Using a Colder Treatment Parameter
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 14, 2014 (Actual)
Primary Completion Date
March 13, 2015 (Actual)
Study Completion Date
March 31, 2015 (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.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the performance of a cryolipolysis system using a colder treatment parameter for non-invasive reduction of subcutaneous fat in the lateral thighs.
Detailed Description
Evaluation of the Zeltiq CoolSculpting System for non-invasive subcutaneous fat reduction in the lateral thighs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Fat Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lateral Thigh Treatment Group
Arm Type
Experimental
Arm Description
CoolSculpting treatment in the lateral thighs for non-invasive subcutaneous fat reduction.
Intervention Type
Device
Intervention Name(s)
The Zeltiq CoolSculpting System
Intervention Description
The CoolSculpting System delivers non-invasive cooling for the reduction of subcutaneous fat.
Primary Outcome Measure Information:
Title
Safety of the Zeltiq CoolSculpting System in the Outer Thighs
Description
Tabulation of device and/or procedure-related adverse events and unanticipated adverse device effects will be performed. Adverse event information will be collected from the time of study enrollment through the 12 week follow-up visit. The Investigator will determine if an adverse event is related to the device and/or study procedure.
Time Frame
Enrollment through 12 week post-final treatment follow-up visit
Secondary Outcome Measure Information:
Title
Percentage of Correctly Identified Pre-treatment Photographs
Description
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 2 out of 3 reviewers.
Time Frame
12 weeks post-final treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female subjects > 22 years of age and < 65 years of age.
Subject has clearly visible fat on the intended treatment area (lateral thighs), which 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 35. 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%) by not making any major changes in their 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 and/or body contouring procedure in the area of intended treatment within the past 4 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 during the study period (in the next 4 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Bachelor, MD
Organizational Affiliation
Innovation Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innovation Research Center
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fat Layer Reduction in the Lateral Thighs Using CoolSculpting
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