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Completed

NCT Number: NCT00762307

Non-invasive Cooling of Subcutaneous Fat

The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat.

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Key information

Conditions

Fat Disorder Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Investigational Site, Dublin, California, United States

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About this study

The purpose of this study is to evaluate a non-invasive cooling device to determine if cold exposure will consistently result in a reduction of subcutaneous fat using the Zeltiq Dermal Cooling device.

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.
  • Subject has clearly visible fat on the flanks, thighs, abdomen, or back.
  • Subject has not had weight change fluctuations exceeding 10 pounds in the preceding month.
  • Subject has read and signed a written informed consent form.

Exclusion criteria

  • Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment within the past 2 years.
  • Subject has a known history of subcutaneous injections into the area of intended treatment (e.g., cortisone) within the past 6 months.
  • Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
  • Subject is taking diet pills within the past 6 months.
  • Subject is unable or unwilling to comply with the study requirements.
  • Subject has any dermatological conditions or scars within the location of the test sites that may interfere with the treatment or evaluation.
  • Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
  • Patient is pregnant or intending to become pregnant in the next 9 months.
  • Patient is lactating or has been lactating in the past 9 months.
  • Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.

Treatment and study plan

Zeltiq Dermal Cooling Device

Device

Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.

Primary outcomes

  1. Change in Fat Layer Thickness of the Treated Flank

    Time frame: Baseline and 6 months

    The change in fat layer thickness as demonstrated by measurement of fat layer layer thickness using ultrasound images taken in the treated area and on the contralateral flank (control) at baseline and at the 6 month follow-up. Data collected on the untreated side and the treated side will be combined to determine the normalized change in fat layer thickness for each subject. The mean percent fat layer reduction across all treatment groups will be presented, as well as for each treatment group.

  2. Percentage of Subjects Expressing Satisfaction With the Procedure

    Time frame: 6 months post-treatment follow-up visit

    Subject satisfaction as determined by the completion of a questionnaire at the 6 month follow-up visit, and, as requested, any other follow-up visits.

  3. Percentage of Correctly Identified Pre-treatment Photographs

    Time frame: Baseline and 6 months

    Change in the treated vs. untreated areas will be assessed for changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the control and treated flanks. Reviewers will be practicing dermatologists. All reviewers will be blinded to post-treatment vs. baseline and/or untreated flank. 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. Results reflect the percentage of correctly identified images.

Sponsors and collaborators

Lead sponsor

Zeltiq Aesthetics

Industry

Registry information

Official study title

A Prospective, Multi-Center Clinical Study of Non-Invasive Cooling of Subcutaneous Fat

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Sep 30, 2008
Registry last updated
Jun 9, 2021

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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