CoolSculpting the Flanks (CSI)
Primary Purpose
Body Fat Disorder
Status
Unknown status
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 flanks, which in the investigator's opinion, may benefit from the treatment.
- No weight change exceeding 5% of body weight 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%) 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, 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 8 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.
- 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
- Laser & Skin Surgery Center of Northern California
- SkinCare Physicians of Chestnut Hill
- Zel Skin & Laser Specialist
- Laser & Skin Surgery Center of New York
- Brian S. Biesman, MD
- EpiCenter Skincare and Laser Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fat Reduction
Arm Description
The treatments are designed to see if the fat can be reduced in the flanks with a new applicator design.
Outcomes
Primary Outcome Measures
Safety endpoint in relation to adverse events
Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs
Effectiveness endpoint gauged by reduction in fat layer thickness
Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.
Secondary Outcome Measures
Subject survey
Subject survey as assessed by questionnaire administered at the final post-treatment visit.
Photo review
Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03304925
Brief Title
CoolSculpting the Flanks
Acronym
CSI
Official Title
CoolSculpting the Flanks
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)
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 safety and efficacy of non-invasive subcutaneous fat layer reduction in the flanks.
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
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Fat Reduction
Arm Type
Experimental
Arm Description
The treatments are designed to see if the fat can be reduced in the flanks with a new applicator design.
Intervention Type
Device
Intervention Name(s)
The ZELTIQ System
Intervention Description
The CoolSculpting machine will be used to perform the treatments.
Primary Outcome Measure Information:
Title
Safety endpoint in relation to adverse events
Description
Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs
Time Frame
Final post treatment visit
Title
Effectiveness endpoint gauged by reduction in fat layer thickness
Description
Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.
Time Frame
Final post-treatment visit
Secondary Outcome Measure Information:
Title
Subject survey
Description
Subject survey as assessed by questionnaire administered at the final post-treatment visit.
Time Frame
Final post-treatment visit
Title
Photo review
Description
Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers.
Time Frame
Final post-treatment visit
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 flanks, which in the investigator's opinion, may benefit from the treatment.
No weight change exceeding 5% of body weight 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%) 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, 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 8 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.
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
Kerrie Jiang, NP
Organizational Affiliation
Zeltiq Aesthetics
Official's Role
Study Director
Facility Information:
Facility Name
Innovation Research Center
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
Facility Name
Laser & Skin Surgery Center of Northern California
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
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
Zel Skin & Laser Specialist
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55424
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
Brian S. Biesman, MD
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
EpiCenter Skincare and Laser Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
95231
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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CoolSculpting the Flanks
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