- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01623037
Pilot Study on The Flanks of Asian Patients
October 23, 2020 updated by: Zeltiq Aesthetics
Pilot Study of Non-Invasive Fat Layer Reduction in the Flanks of Asian Patients With the CoolCurve+ Applicator
This study will evaluate CoolSculpting and the CoolCurve applicator for non-invasive fat reduction in the flanks with sharp body curvature.
Study Overview
Detailed Description
The purpose of this study is to evaluate the performance of the CoolCurve+ applicator for non-invasive fat layer reduction in flanks for Asian patient population.
Study Type
Interventional
Enrollment (Actual)
15
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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Hong Kong
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Hong Kong, Hong Kong, China
- Hong Kong Dermatology and Laser Centre
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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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria
- Male or female subjects > 18 years of age.
- Subjects must be of Asian descent.
- Subject has clearly visible fat on the flanks, 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 25. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- Subject with sharp flank curvature that fits well with the CoolCurve+ applicator.
- Subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle 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, abdominoplasty, 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 6 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 for weight loss 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 4 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.
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CoolSculpting Treatment Group
The single arm will include all subjects treated on each flank with the CoolSculpting System and CoolCurve+ applicator.
Treatment temperature and duration are defined in the protocol.
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Non-invasive cooling is applied to the each flank with a defined cooling rate and duration.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Pre-treatment Images Correctly Identified
Time Frame: Baseline and 12 weeks post-final 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 and 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 is defined as 70% correct identification of pre-treatment images.
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Baseline and 12 weeks post-final treatment
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Safety of the CoolSculpting and the CoolCurve+ Applicator
Time Frame: Enrollment through 12 weeks post-final treatment
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The number of device- or procedure-related adverse events will be tabulated for all AEs reported continuously throughout the study, from enrollment to the final 12 week follow-up visit.
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Enrollment through 12 weeks post-final treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subject Satisfaction With the Procedure
Time Frame: 12 weeks post final treatment
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Subject satisfaction as assessed by questionnaire administered at 12-weeks post-treatment will be tabulated.
The questionnaire will be composed of 5-point Likert scale questions, as well as free-text responses.
Subjects will be asked to determine overall satisfaction with the treatment.
The choices will be: 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither unsatisfied nor satisfied; 4) somewhat satisfied; 5) very satisfied.
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12 weeks post final treatment
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Change in the Fat Layer Thickness
Time Frame: Pre-treatment and 12 weeks post-final treatment
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Caliper measurements will be obtained prior to treatment and at the 12-week follow-up visit to assess for changes to the fat layers in the flanks.
After the treatment area is identified and marked, the thickness of fat layer will be measured using a caliper at the middle of the fat bulge.
For each treatment area, three (3) measurements will be taken and recorded.
The average of the three measurements will be calculated.
The location of where measurements were taken will be recorded on a transparency sheet along with reference points using the subject's body landmarks (such as a mole, skin pigmentation).
This transparency will be used at post treatment visit to locate the measurement sites.
Results will be reported in millimeters of fat layer.
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Pre-treatment and 12 weeks post-final treatment
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Operator Feedback
Time Frame: Pre-treatment/treatment day
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Operator performing or assisting with study procedure will complete two questionnaire at the treatment visit regarding the fit of two applicators: 1) CoolCurve+ and 2) CoolCurve The questionnaire consists of four multiple choice questions, each having a 5-point scale, with '5' representing the best and '1' the worst.
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Pre-treatment/treatment day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Henry Chan, MD, Hong Kong Dermatology and Laser Centre
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
June 21, 2012
Primary Completion (ACTUAL)
September 21, 2012
Study Completion (ACTUAL)
December 1, 2012
Study Registration Dates
First Submitted
June 14, 2012
First Submitted That Met QC Criteria
June 18, 2012
First Posted (ESTIMATE)
June 19, 2012
Study Record Updates
Last Update Posted (ACTUAL)
November 17, 2020
Last Update Submitted That Met QC Criteria
October 23, 2020
Last Verified
June 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZA12-006
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.
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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