Clinical trial NCT01517659: Non-Invasive Reduction of Fat in the Inner Thighs
Official title: Non-Invasive Reduction of Fat in the Inner Thighs With the Zeltiq Coolsculpting System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Fat Disorder
Keywords: Cryolipolysis
Fat Reduction
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2012-01-25
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: TREATMENT

Brief summary: Evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the ZELTIQ CoolSculpting System.

Detailed description: The Zeltiq CoolSculpting System, which reduces subcutaneous fat in specific areas of the body, will be studied for safety and efficacy when used in the inner thigh.

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 inner thighs and 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 his/her 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, 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 (e.g., heparin, insulin) into the area of intended treatment 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 a 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 intends to become pregnant in the next 8 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: Percentage of Pre-Treatment Images Correctly Identified by Reviewers
timeFrame: 16 weeks post-treatment
measure: Safety of the CoolSculpting Device and/or Procedure
timeFrame: Enrollment through 16 weeks post-treatment
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: 16 weeks post-treatment
measure: Reduction in Fat Layer Thickness in the Treated Area as Measured by Ultrasound
timeFrame: 16 week-post-treatment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Laser & Skin Surgery Center of Northern California
state: California
city: Edina
country: United States
facility: Zel Skin and Laser Specialists
state: Minnesota
city: Dallas
country: United States
facility: Dallas Plastic Surgery Institute
state: Texas
Study officials:
affiliation: Laser and Skin Surgery Center of Northern California
name: Suzanne Kilmer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zelickson BD, Burns AJ, Kilmer SL. Cryolipolysis for safe and effective inner thigh fat reduction. Lasers Surg Med. 2015 Feb;47(2):120-7. doi: 10.1002/lsm.22320. Epub 2015 Jan 13.