CoolSculpting of the Flank With Alternate Treatment Parameters

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-18

Study Completion Date

2014-06-27

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction with an alternative treatment parameter.

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Detailed Description

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The study evaluated the use of the Zeltiq CooSculpting System for non-invasive fat removal in the flank.

Conditions

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Body Fat Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CoolSculpting of the Flank With Alternate Treatment Parameters

Each subject served as their own control with 1 flank treated with CoolSculpting; the contralateral flank was untreated.

Group Type EXPERIMENTAL

The Zeltiq CoolSculpting System

Intervention Type DEVICE

Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Interventions

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The Zeltiq CoolSculpting System

Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.

Intervention Type DEVICE

Other Intervention Names

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Cryolipolysis Lipolysis

Eligibility Criteria

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Inclusion Criteria

1. Male or female subjects \> 18 years of age and \< 65 years of age.
2. Subject has clearly visible fat on the flanks, 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 12 months.
4. 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.
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 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 intending to become pregnant during the study period (in the next 5 months).
12. Subject is lactating or has been lactating in the past 6 months.
13. Subject has a history of hernia in the areas to be treated.
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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes