- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02554760
Bilateral; Flank Study With Crown Cooling Insert (CCI)
October 1, 2020 updated by: Zeltiq Aesthetics
CoolSculpting the Flank Using an Applicator With a Crown Cooling Insert
Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flank using an applicator with and without the Crown Cooling Insert.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will evaluate the Zeltiq CoolSculpting System when used with the standard CoolCore applicator and the CoolCore Applicator and the Crown Cooling Insert accessory.
Study Type
Interventional
Enrollment (Actual)
19
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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Sacramento, California, United States, 95816
- Laser and Skin Surgery of Northern California
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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 5 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: All Study Participants
This is a split body study in which all subjects will receive bilateral flank treatment with CoolSculpting.
The investigator will determine one flank for treatment using the CoolCore applicator without an accessory for a duration of 60 minutes at a protocol-defined temperature.
The contralateral flank will be treated with the standard CoolCore Applicator using an applicator accessory, the Crown Cooling Insert (CCI) at a protocol-defined temperature for a duration of up to 45 minutes.
All enrolled subjects receive identical treatments; the investigator will use alternate subject numbers to balance which flank to treat with and without the CoolCore applicator accessory, such that all even subject numbers will receive treatment using the Standard CoolCore on the right flank and odd subject numbers will receive the same treatment on the left flank.
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The CoolSculpting device and CoolCore applicator with and without the Crown Cooling Insert 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 |
---|---|---|
Percentage of Correctly Identified Pre-treatment Photos by a Panel of Blinded Independent Reviewers
Time Frame: 12 weeks post-treatment
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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 will be defined as at least 70% correct identification of the pre-treatment images for flanks treated with each treatment parameter by at least 2 of 3 reviewers.
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12 weeks post-treatment
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Safety of the Zeltiq CoolSculpting System Using the CoolCore Applicator With and Without the Crown Cooling Insert
Time Frame: Enrollment through the 12 week post-treatment follow-up visit
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The safety endpoint is the number of unanticipated adverse device effects (UADE) as well as the number of device and/or procedure-related adverse events.
Adverse events are collected from the time of enrollment through the 12 week final follow-up visit.
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Enrollment through the 12 week post-treatment follow-up visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Satisfaction
Time Frame: 12 weeks post-treatment
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Subject satisfaction as assessed by questionnaire administered at 12 weeks post-treatment.
The questionnaire will consist of a 5-point Likert scale with the following selections options: 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither satisfied nor unsatisfied; 4) somewhat satisfied; 5) very satisfied.
jIn addition, free-text fields provided options for subjects responses.
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12 weeks post-treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Suzanne Kilmer, MD, Laser and Skin Surgery Center of Northern California
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
September 15, 2015
Primary Completion (Actual)
December 17, 2015
Study Completion (Actual)
December 17, 2015
Study Registration Dates
First Submitted
September 16, 2015
First Submitted That Met QC Criteria
September 16, 2015
First Posted (Estimate)
September 18, 2015
Study Record Updates
Last Update Posted (Actual)
October 26, 2020
Last Update Submitted That Met QC Criteria
October 1, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZA15-004
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 device product
Yes
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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