Fat Layer Reduction in the Lateral Thighs Using CoolSculpting

NCT ID: NCT02324816

Last Updated: 2021-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-14
• Study Completion Date: 2015-03-31

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.

Conditions

Body Fat Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lateral Thigh Treatment Group

CoolSculpting treatment in the lateral thighs for non-invasive subcutaneous fat reduction.

Group Type: EXPERIMENTAL

The Zeltiq CoolSculpting System

Intervention Type: DEVICE

The CoolSculpting System delivers non-invasive cooling for the reduction of subcutaneous fat.

Interventions

The Zeltiq CoolSculpting System

The CoolSculpting System delivers non-invasive cooling for the reduction of subcutaneous fat.

Intervention Type: DEVICE

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 35. 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
• Subject is pregnant or intending to become pregnant during the study period (in the next 4 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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zeltiq Aesthetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Bachelor, MD

Role: PRINCIPAL_INVESTIGATOR

Innovation Research Center

Locations

Innovation Research Center

Pleasanton, California, United States

Countries

United States

Other Identifiers

ZA14-005

Identifier Type: -

Identifier Source: org_study_id