Non-Invasive Fat Layer Reduction in the Lateral Thighs With a Cryolipolysis System Using a Colder Treatment Parameter

Zeltiq Aesthetics1 site in 1 country19 target enrollmentNovember 14, 2014

ConditionsBody Fat Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Body Fat Disorder
Sponsor: Zeltiq Aesthetics
Enrollment: 19
Locations: 1
Primary Endpoint: Safety of the Zeltiq CoolSculpting System in the Outer Thighs
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Evaluate the performance of a cryolipolysis system using a colder treatment parameter for non-invasive reduction of subcutaneous fat in the lateral thighs.

Detailed Description

Evaluation of the Zeltiq CoolSculpting System for non-invasive subcutaneous fat reduction in the lateral thighs.

Registry

clinicaltrials.gov

Start Date

November 14, 2014

End Date

March 31, 2015

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zeltiq Aesthetics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subjects \> 22 years of age and \< 65 years of age.
•Subject has clearly visible fat on the intended treatment area (lateral thighs), 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
•BMI is defined as weight in pounds multiplied by 703 divided by the square of the height in inches.
•Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in their diet or exercise routine 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, 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 4 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

Outcomes

Primary Outcomes

Safety of the Zeltiq CoolSculpting System in the Outer Thighs

Time Frame: Enrollment through 12 week post-final treatment follow-up visit

Tabulation of device and/or procedure-related adverse events and unanticipated adverse device effects will be performed. Adverse event information will be collected from the time of study enrollment through the 12 week follow-up visit. The Investigator will determine if an adverse event is related to the device and/or study procedure.