Clinical trial NCT01623037: Pilot Study on The Flanks of Asian Patients
Official title: Pilot Study of Non-Invasive Fat Layer Reduction in the Flanks of Asian Patients With the CoolCurve+ Applicator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Fat Disorder
Keywords: Lipolysis
Cryolipolysis
Fat Reduction
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2012-06-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will evaluate CoolSculpting and the CoolCurve applicator for non-invasive fat reduction in the flanks with sharp body curvature.

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.

Eligibility criteria: Inclusion Criteria

1. Male or female subjects \> 18 years of age.
2. Subjects must be of Asian descent.
3. Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
4. Subject has not had weight change exceeding 10 pounds in the preceding month.
5. 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.
6. Subject with sharp flank curvature that fits well with the CoolCurve+ applicator.
7. 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.
8. 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 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.
5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
6. 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.
7. 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.
8. Subject is taking or has taken diet pills or supplements for weight loss within the past month.
9. 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).
10. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
11. Subject is pregnant or intending to become pregnant during the study period (in the next 4 months).
12. Subject is lactating or has been lactating in the past 6 months.
13. Subject is unable or unwilling to comply with the study requirements.
14. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
15. 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: Proportion of Pre-treatment Images Correctly Identified
timeFrame: Baseline and 12 weeks post-final treatment
measure: Safety of the CoolSculpting and the CoolCurve+ Applicator
timeFrame: Enrollment through 12 weeks post-final treatment
Secondary outcomes:
measure: Subject Satisfaction With the Procedure
timeFrame: 12 weeks post final treatment
measure: Change in the Fat Layer Thickness
timeFrame: Pre-treatment and 12 weeks post-final treatment
measure: Operator Feedback
timeFrame: Pre-treatment/treatment day
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Hong Kong Dermatology and Laser Centre
state: Hong Kong
Study officials:
affiliation: Hong Kong Dermatology and Laser Centre
name: Henry Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: