Back to resultsCoolSculpting of the Distal Thigh Study (DST)
Primary Purpose
Body Fat Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The ZELTIQ System
Sponsored by
About this trial
This is an interventional other 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 distal thigh, 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 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% of total body weight) 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 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, 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 5 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
- Bowes Dermatology Group
- SkinCare Physicians of Chestnut Hill
- Laser & Skin Surgery Center of New York
- Nashville Centre for Laser and Facial Surgery
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with Small Area Applicator
Arm Description
Each enrolled subject was treated on a single thigh, in the distal region.
Outcomes
Primary Outcome Measures
Rate of Device- or Procedure-related Adverse Events
The number of device- or procedure-related adverse events will be tabulated. Adverse event data are collected throughout the study period from the time of enrollment through the final follow-up visit.
Proportion of Correctly Identified Photos by Blinded 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. 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.
Note: Due to the inconsistency of site photographic practices, the photos were not reasonably evaluable and therefore the independent phot review was not conducted.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02335749
Brief Title
CoolSculpting of the Distal Thigh Study
Acronym
DST
Official Title
CoolSculpting Treatment of the Distal Thigh
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 17, 2014 (Actual)
Primary Completion Date
November 9, 2015 (Actual)
Study Completion Date
November 9, 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.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluate the safety and efficacy of the ZELTIQ CoolSculpting System using a small area applicator for non-invasive subcutaneous fat reduction in the distal thigh.
Detailed Description
This study will investigate the use of a Small Area Applicator with the CoolSculpting device for reducing subcutaneous fat in the distal thigh. The study will evaluate the safety and effectiveness of treatments.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with Small Area Applicator
Arm Type
Experimental
Arm Description
Each enrolled subject was treated on a single thigh, in the distal region.
Intervention Type
Device
Intervention Name(s)
The ZELTIQ System
Other Intervention Name(s)
CoolSculpting System
Intervention Description
The CoolSculpting System with a Small Area Applicator will be used to deliver treatments.
Primary Outcome Measure Information:
Title
Rate of Device- or Procedure-related Adverse Events
Description
The number of device- or procedure-related adverse events will be tabulated. Adverse event data are collected throughout the study period from the time of enrollment through the final follow-up visit.
Time Frame
Study enrollment through 12-week final follow-up visit, approximately 15 weeks
Title
Proportion of Correctly Identified Photos by Blinded Reviewers
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. 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.
Note: Due to the inconsistency of site photographic practices, the photos were not reasonably evaluable and therefore the independent phot review was not conducted.
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 distal thigh, 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 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% of total body weight) 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 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, 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 5 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.
Facility Information:
Facility Name
Bowes Dermatology Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
SkinCare Physicians of Chestnut Hill
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Facility Name
Laser & Skin Surgery Center of New York
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Nashville Centre for Laser and Facial Surgery
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CoolSculpting of the Distal Thigh Study
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