Clinical trial NCT02081196: CoolSculpting of the Flank With Alternate Treatment Parameters
Official title: Non-Invasive Reduction of Subcutaneous Fat Layer With an Alternative Treatment Parameter
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: 2014-03-07
Enrollment: 45
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: The purpose of this study is to evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction with an alternative treatment parameter.

Detailed description: The study evaluated the use of the Zeltiq CooSculpting System for non-invasive fat removal in the flank.

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 the flanks, which in the investigator's opinion, may benefit from the treatment.
3. Subject has not had weight change exceeding 10 pounds in the preceding month.
4. Subject with body mass index (BMI) up to 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 has had a surgical procedure(s) in the area of intended treatment.
2. Subject has had an invasive fat reduction procedure (e.g., liposuction, 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 12 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 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 5 months).
12. Subject is lactating or has been lactating in the past 6 months.
13. Subject has a history of hernia in the areas to be treated.
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: The Number of Device and/or Procedure-Related Adverse Events
timeFrame: Enrollment through 16 weeks post-treatment visit, which is approximately 5 months
measure: Change in the Fat Layer of the Treated Area as Measured by Ultrasound
timeFrame: Pre-treatment and 16 weeks post-treatment
Secondary outcomes:
measure: Proportion of Pre-treatment Images Correctly Identified.
timeFrame: 16 weeks post-treatment
measure: Subject Satisfaction
timeFrame: 16 weeks post-treatment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser & Skin Surgery Center of Northern California
state: California
city: Dallas
country: United States
facility: Dallas Plastic Surgery Institute
state: Texas
city: Vancouver
country: Canada
facility: Arbutus Laser Centre
state: British Columbia
Study officials:
affiliation: Laser and Skin Surgery Center of Northern California
name: Suzanne Kilmer, MD
role: PRINCIPAL_INVESTIGATOR
References: