Fat Reduction in the AbdomenNCT01377740
Non-Invasive Reduction of Abdominal Fat Utilizing the CoolFlex and eZ App 6.3 Applicators
A study testing The Zeltiq System in people with Fat Reduction in the Abdomen, run by Zeltiq Aesthetics at 2 sites in Canada.
Trial summary
This study is being performed to reduce unwanted abdominal fat using two different applicators for the Zeltiq System. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fat Reduction in the Abdomen
- What is being tested?
- The Zeltiq System
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Institute of Cosmetic and Laser Surgery
Oakville, Ontario, L6J 7W5
Arbutus Laser Centre
Vancouver, British Columbia, V6J IZ6
About this study
This study is being performed to reduce unwanted abdominal fat using two different applicators for the Zeltiq System.
Read the 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.
- Conditions
- Fat Reduction in the Abdomen
- Being tested
- The Zeltiq System
- Keywords
- Lipolysis, Cryolipolysis, Fat Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Zeltiq SystemDevice
Also called Cryolipolysis, Lipolysis
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
What is being measured
The primary outcome is the main question the study is designed to answer.
Independent imaging review
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%.
Measured: 16 weeks
Secondary outcomes (2)
Overall reduction
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).
Measured: 16 weeks
Subject satisfaction
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat Reduction in the AbdomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeltiq Aesthetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerald Boey, MD, Principal investigator, Arbutus Laser Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377740
- Sponsor's protocol ID
- ZA11-001
- Status last verified
- Jan 2012
- First submitted
- 16 Jun 2011
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Reduction of Abdominal Fat Utilizing the CoolFlex and eZ App 6.3 Applicators
- ClinicalTrials.gov ID
- NCT01377740
- Acronym / sponsor ID
- ZA11-001
- Conditions
- Fat Reduction in the Abdomen
- Keywords
- Lipolysis, Cryolipolysis, Fat Reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zeltiq AestheticsIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 21 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being performed to reduce unwanted abdominal fat using two different applicators for the Zeltiq System.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Zeltiq SystemAlso: Cryolipolysis, LipolysisNon-invasive cooling is applied to the treatment area with a defined cooling rate and duration. | Device | – |
Primary outcome
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%.
2 secondary outcomes
Overall reduction
Time frame: 16 weeks
Subject satisfaction
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Boey, MD principal investigator
Arbutus Laser Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Zeltiq System in people with Fat Reduction in the Abdomen, run by Zeltiq Aesthetics at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Independent imaging review (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2017; AzTrials last refreshed its copy on 6 Nov 2026.