Clinical trial NCT02081209: Outer Thigh Study With Varied Treatment Parameters
Official title: Non-Invasive Fat Layer Reduction in the Lateral Thighs With a Cryolipolysis System Using Varied Treatment Parameters
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: 40
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
Intervention model description: All subjects to be treated on one lateral thigh at a protocol-defined temperature for 120 minutes. Treatment of the contralateral thigh was performed using two unique protocol-defined temperatures for 60 minutes.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the performance of the Zeltiq CoolSculpting System using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.

Detailed description: The purpose of this study is to compare the performance of a cryolipolysis system using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.

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 intended treatment area (lateral thighs), 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 2 months.
4. Subject has significant asymmetry between the lateral thighs.
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 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 during the study period (in the next 5 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: Safety of the Zeltiq Device
timeFrame: Time of enrollment though16 weeks post-treatment (approximately 5 months)
measure: Safety of the Zeltiq Device
timeFrame: From enrollment through 16 week follow-up (approximately 5 months)
measure: Percentage of Pre-treatment Images Correctly Identified.
timeFrame: Baseline and 16 weeks post-treatment
Secondary outcomes:
measure: Change in the Fat Layer of the Treated Area as Measured by Ultrasound
timeFrame: 16 weeks post-treatment
measure: Subject Satisfaction
timeFrame: 16-weeks post treatment
Other outcomes:
Locations:
city: Marina Del Rey
country: United States
facility: Marina Plastic Surgery
state: California
city: Pleasanton
country: United States
facility: Innovation Research Center
state: California
Study officials:
affiliation: Innovation Research Center
name: Eric Bachelor, MD
role: PRINCIPAL_INVESTIGATOR
References: