- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03304925
CoolSculpting the Flanks (CSI)
August 14, 2020 updated by: Zeltiq Aesthetics
Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flanks.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
320
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Pleasanton, California, United States, 94588
- Innovation Research Center
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Sacramento, California, United States, 95816
- Laser & Skin Surgery Center of Northern California
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Massachusetts
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Chestnut Hill, Massachusetts, United States, 02467
- SkinCare Physicians of Chestnut Hill
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Minnesota
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Edina, Minnesota, United States, 55424
- Zel Skin & Laser Specialist
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New York
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New York, New York, United States, 10016
- Laser & Skin Surgery Center of New York
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Tennessee
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Nashville, Tennessee, United States, 37203
- Brian S. Biesman, MD
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Texas
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Dallas, Texas, United States, 95231
- EpiCenter Skincare and Laser Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fat Reduction
The treatments are designed to see if the fat can be reduced in the flanks with a new applicator design.
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The CoolSculpting machine will be used to perform the treatments.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety endpoint in relation to adverse events
Time Frame: Final post treatment visit
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Measurement of device- or procedure-related adverse events.
It is expected there will be zero UADEs
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Final post treatment visit
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Effectiveness endpoint gauged by reduction in fat layer thickness
Time Frame: Final post-treatment visit
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Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.
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Final post-treatment visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject survey
Time Frame: Final post-treatment visit
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Subject survey as assessed by questionnaire administered at the final post-treatment visit.
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Final post-treatment visit
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Photo review
Time Frame: Final post-treatment visit
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Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers.
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Final post-treatment visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kerrie Jiang, NP, Zeltiq Aesthetics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 25, 2017
Primary Completion (Anticipated)
August 1, 2022
Study Completion (Anticipated)
August 1, 2022
Study Registration Dates
First Submitted
October 3, 2017
First Submitted That Met QC Criteria
October 3, 2017
First Posted (Actual)
October 9, 2017
Study Record Updates
Last Update Posted (Actual)
August 18, 2020
Last Update Submitted That Met QC Criteria
August 14, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZA17-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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