Clinical trial NCT01728857: Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction
Official title: The Effects of Tissue Optimization on Cryolipolysis Procedures for Fat Layer Reduction
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: 2012-11-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Evaluate the effects of tissue optimization before and during cryolipolysis procedures on the outcome of non-invasive fat reduction using the ZELTIQ System.


Eligibility criteria: Inclusion Criteria

1. Male or female subjects \> 18 years of age and \< 65 years of age.
2. Subject has clearly visible fat on intended treatment area, which in the investigator's opinion, may benefit from the treatment(s).
3. Subject has not had weight change exceeding 10 pounds in the preceding month.
4. Subject with body mass index (BMI) less than 30. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
5. 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.
6. Subject has read and signed a written informed consent form.

Exclusion Criteria

1. Subject presents a significant asymmetry of intended treatment areas.
2. Subject has had a surgical procedure(s) in the area of intended treatment in the past 5 years.
3. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment in the past 5 years.
4. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
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 is taking or has taken diet pills or weight control supplements within the past month.
10. 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).
11. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system.
12. Subject is pregnant or intending to become pregnant in the next 5 months.
13. Subject is lactating or has been lactating in the past 6 months.
14. Subject has a history of hernia in the areas to be treated.
15. Subject is unable or unwilling to comply with the study requirements.
16. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
17. 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: Percentage of Before and After Side-by-side Photographs Correctly Identified by At Least 2 of 3 Blinded Reviewers From the Independent Physician Reviewer (IPR) Panel
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change From Baseline in Reduction of Fat Layer Thickness as Assessed by Ultrasound
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Pleasanton
country: United States
facility: Innovation Research Center
state: California
Study officials:
affiliation: Zeltiq Aesthetics
name: Director Clinical Development - Body Contouring
role: STUDY_DIRECTOR
References: