Clinical trial NCT01600638: Non-Invasive Reduction of Fat in the Flanks of Patients With Sharp Body Curvature
Official title: Non-Invasive Reduction of Fat in the Flanks of Patients With Sharp Body Curvature
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: 2012-05-17
Enrollment: 25
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 the ZELTIQ System and the CoolCurve+ applicator for non-invasive fat reduction in flanks for a patient population with sharp body curvature.

Detailed description: The Zeltiq System with the CoolCurve+ applicator will be evaluated for safety and effectiveness in subjects with subcutaneous fat on the flanks and who have sharp body curvatures. The curvature of interest is typical of individuals who are relatively thin with a small body frame.

Eligibility criteria: Inclusion Criteria

* Male or female subjects \> 18 years of age and \< 65 years of age.
* Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
* Subject has not had weight change exceeding 10 pounds in the preceding month.
* Subject with body mass index (BMI) up to 29. BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
* Subject with sharp flank curvature that fits well with the CoolCurve+ applicator.
* 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.
* Subject has read and signed a written informed consent form.

Exclusion Criteria

* Subject has had a surgical procedure(s) in the area of intended treatment.
* Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment.
* Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 12 months.
* 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.
* Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
* 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.
* 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.
* Subject is taking or has taken diet pills or supplements within the past month.
* 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).
* Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
* Subject is pregnant or intending to become pregnant during the study period (in the next 5 months).
* Subject is lactating or has been lactating in the past 6 months.
* Subject is unable or unwilling to comply with the study requirements.
* Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
* 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 System for Non-invasive Fat Reduction in Subjects With Greater Flank Curvature.
timeFrame: 8 weeks and 16 weeks post final treatment
measure: Change in Fat Layer Thickness When Compared to Untreated Control
timeFrame: 16 weeks post final treatment
Secondary outcomes:
measure: Proportion of Pre-treatment Images Correctly Identified
timeFrame: 16 weeks post final treatment
measure: Subject Satisfaction Questionnaire
timeFrame: 16 weeks post final treatment
measure: Additional Safety Evaluation
timeFrame: Enrollment though 16 weeks post final treatment
Other outcomes:
Locations:
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: