Clinical trial NCT01377740: Non-Invasive Reduction of Abdominal Fat Utilizing the CoolFlex and eZ App 6.3 Applicators
Official title: Non-Invasive Reduction of Abdominal Fat Utilizing the CoolFlex and eZ App 6.3 Applicators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Reduction in the Abdomen
Keywords: Lipolysis
Cryolipolysis
Fat Reduction
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2011-06-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Female subjects \> 18 years of age and \< 65 years of age.
2. Subject has clearly visible fat on the abdomen. (Figure 1)
3. Subject has not had weight change exceeding 10 pounds in the preceding month.
4. 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.
5. Subject has read and signed a written informed consent form.

Exclusion Criteria:

1. Subject has had a surgical procedure(s) in the area of intended treatment.
2. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment.
3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
4. Subject has discernable asymmetry or contour irregularity in the intended treatment area.
5. 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.
6. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
7. 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.
8. 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.
9. 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.
10. Subject is taking or has taken diet pills or supplements within the past month.
11. 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.
12. Subject is pregnant or intending to become pregnant in the next 6 months.
13. Subject is lactating or has been lactating in the past 6 months.
14. Subject is unable or unwilling to comply with the study requirements.
15. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
16. 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.

Primary outcomes:
measure: Independent imaging review
timeFrame: 16 weeks
Secondary outcomes:
measure: Overall reduction
timeFrame: 16 weeks
measure: Subject satisfaction
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Arbutus Laser Centre
state: British Columbia
city: Oakville
country: Canada
facility: Institute of Cosmetic and Laser Surgery
state: Ontario
Study officials:
affiliation: Arbutus Laser Centre
name: Gerald Boey, MD
role: PRINCIPAL_INVESTIGATOR
References: