- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04506307
CoolSculpting System (ELI)
August 6, 2020 updated by: Zeltiq Aesthetics
Noninvasive Fat Reduction With the CoolSculpting System
Evaluate the safety and efficacy of multiple, simultaneous CoolSculpting cycles for the purpose of non-invasive fat reduction.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
60
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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Marina Del Rey, California, United States, 90292
- Marina Plastic Surgery
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Florida
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Miami, Florida, United States, 33133
- Riverchase Dermatology
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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
- Subject (healthy volunteer) has read and signed the study written informed consent form.
- Male or female ≥ 22 years and ≤65 years of age.
- Subject has clearly visible fat in one or more areas on the torso (abdomen, flank, back fat, bra fat), which in the investigator's opinion, may benefit from the treatment.
- Subject has not had weight change exceeding 5% of body weight in the preceding month.
- 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 study.
- Subject has a BMI ≤ 30 as determined at screening.
- Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.
Exclusion Criteria
- Subject has had a recent surgical procedure 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, paroxysmal cold hemoglobinuria, or cold agglutinin disease.
- Subject has a known sensitivity to cold, such as cold urticaria, Raynaud's disease, chilblains (pernio), 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 has a history of hernia in the area(s) to be treated.
- 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 is unable or unwilling to comply with the study requirements.
- Subject is currently enrolled in a clinical study of any 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 torso area 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 |
---|---|---|
Efficacy Endpoint: Independent Photo Review
Time Frame: one-month post final data collection
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Correct identification of pre-treatment vs. 12-week post-treatment images by at least two out of three blinded, independent reviewers.
Success will be defined as at least 70% correct identification of the pre-treatment images.
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one-month post final data collection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety Endpoint: AE's
Time Frame: one-month post final data collection
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The frequency of device and procedure-related adverse events (AEs), including device-related serious adverse events (SADEs), will be summarized.
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one-month post final data collection
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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)
March 13, 2020
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
August 6, 2020
First Submitted That Met QC Criteria
August 6, 2020
First Posted (Actual)
August 10, 2020
Study Record Updates
Last Update Posted (Actual)
August 10, 2020
Last Update Submitted That Met QC Criteria
August 6, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZA20-001
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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