- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01377740
Non-Invasive Reduction of Abdominal Fat Utilizing the CoolFlex and eZ App 6.3 Applicators
June 20, 2017 updated by: Zeltiq Aesthetics
This study is being performed to reduce unwanted abdominal fat using two different applicators for the Zeltiq System.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary objective of the study is to evaluate the performance of the CoolFlex applicator compared to the performance of the eZ App 6.3 applicator in the treatment of abdominal fat in terms of its ability to achieve a discernable change to the contour of the treated area.
Study Type
Interventional
Enrollment (Actual)
20
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
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6J IZ6
- Arbutus Laser Centre
-
-
Ontario
-
Oakville, Ontario, Canada, L6J 7W5
- Institute of Cosmetic and Laser Surgery
-
-
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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female subjects > 18 years of age and < 65 years of age.
- Subject has clearly visible fat on the abdomen. (Figure 1)
- Subject has not had weight change exceeding 10 pounds in the preceding month.
- Subject agrees to maintain their 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 has discernable asymmetry or contour irregularity in the intended treatment area.
- 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 body mass index (BMI) exceeds 40. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
- 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.
- Subject is pregnant or intending to become pregnant in the next 6 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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Independent imaging review
Time Frame: 16 weeks
|
The primary effectiveness endpoint is the percent of reviews by the reviewers which either identify no clinically significant difference in fat reduction between the two sides of the abdomen, or identify greater fat reduction on the side of the abdomen treated with the CoolFlex applicator at 8 weeks post-treatment.
It is expected that the percentage of reviews identifying no clinically significant difference between the two sides of the abdomen or identifying greater fat reduction on the side of the abdomen treated with the CoolFlex applicator at 8 weeks post-treatment will be at least 75%.
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall reduction
Time Frame: 16 weeks
|
Overall reduction in the fat layer thickness on each side of the abdomen, as demonstrated by comparison of pre-treatment and 8- and 16-week post-treatment ultrasound measurements, for all evaluable subjects (i.e., adequate ultrasound imaging data sets).
|
16 weeks
|
Subject satisfaction
Time Frame: 16 weeks
|
Subject satisfaction with the Zeltiq procedure as determined by the results of a subject satisfaction questionnaire at the 8- and 16-week follow-up visits.
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gerald Boey, MD, Arbutus 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
July 1, 2011
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
June 16, 2011
First Submitted That Met QC Criteria
June 17, 2011
First Posted (Estimate)
June 21, 2011
Study Record Updates
Last Update Posted (Actual)
June 22, 2017
Last Update Submitted That Met QC Criteria
June 20, 2017
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ZA11-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Fat Reduction in the Abdomen
-
Zeltiq AestheticsCompletedFat Reduction in the Upper ArmCanada
-
Syneron MedicalUnknown
-
University Hospital TuebingenCompleted
-
University Hospital TuebingenGerman Research Foundation; University of Hohenheim; German Center for Diabetes... and other collaboratorsCompleted
-
Rigshospitalet, DenmarkCompletedFocal Liver Lesions | Focal Lesions in the AbdomenDenmark
-
InMode MD Ltd.Active, not recruitingCircumference Reduction of AbdomenUnited States
-
Alma Lasers Inc.Unknown
-
Zeltiq AestheticsCompleted
-
Goldman, Butterwick, Fitzpatrick and GroffAllerganCompletedFat ReductionUnited States
-
University of BaghdadEman Hammad HafithCompleted
Clinical Trials on The Zeltiq System
-
Zeltiq AestheticsActive, not recruiting
-
Zeltiq AestheticsUnknown
-
Zeltiq AestheticsCompleted
-
Zeltiq AestheticsCompleted
-
Zeltiq AestheticsCompleted
-
Zeltiq AestheticsUnknown