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Completed

NCT Number: NCT02081209

Outer Thigh Study With Varied Treatment Parameters

The purpose of this study is to compare the performance of the Zeltiq CoolSculpting System using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.

Completed

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Key information

Conditions

Body Fat Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marina Plastic Surgery, Marina del Rey, California, United States

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About this study

The purpose of this study is to compare the performance of a cryolipolysis system using various treatment parameters for non-invasive reduction of subcutaneous fat in the lateral thighs.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects > 18 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 30. 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 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, 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 2 months.
  • Subject has significant asymmetry between the lateral thighs.
  • 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.

Treatment and study plan

The ZELTIQ CoolSculpting System

Device

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

Other names: Cryolipolysis

Primary outcomes

  1. Safety of the Zeltiq Device

    Time frame: Time of enrollment though16 weeks post-treatment (approximately 5 months)

    The number of device- or procedure-related adverse events will be tabulated from the time of enrollment through the 16 week follow-up visit.

  2. Safety of the Zeltiq Device

    Time frame: From enrollment through 16 week follow-up (approximately 5 months)

    The number of unanticipated adverse device effects (UADEs) will be tabulated.

  3. Percentage of Pre-treatment Images Correctly Identified.

    Time frame: Baseline and 16 weeks post-treatment

    Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 80%.

Secondary outcomes

  1. Change in the Fat Layer of the Treated Area as Measured by Ultrasound

    Time frame: 16 weeks post-treatment

    Change in the fat layer thickness will be calculated by comparison of pre-treatment and 16 week post-treatment ultrasound measurements taken in the area treated with the device, and in the adjacent untreated control area. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes were normalized for each subject by subtracting the change in control (untreated area) from the change in treated area to remove the influence of weight variations. Success is defined as, on average, at least a 1mm or greater reduction in fat layer thickness for the treated region as compared to the untreated control. Results indicate the mean fat layer reduction in mm.

  2. Subject Satisfaction

    Time frame: 16-weeks post treatment

    Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the 16 week follow up visit. The questionnaire is composed of a 5-point Likert scale questions, as well as free text responses. Subjects will be asked to determine overall satisfaction with the treatment. The choices will be 1) very unsatisfied; 2) somewhat unsatisfied; 3) neither unsatisfied or satisfied; 4) somewhat satisfied; 5) very satisfied.

Sponsors and collaborators

Lead sponsor

Zeltiq Aesthetics

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 7, 2014
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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