Pilot Study of CoolTXT for Non-Invasive Fat Reduction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01517646
Recruitment Status : Completed
First Posted : January 25, 2012
Last Update Posted : June 22, 2017
Information provided by (Responsible Party):
Zeltiq Aesthetics

Brief Summary:
This study is being performed to reduce unwanted fat, in various body areas, using a new applicator and control unit for Zeltiq.

Condition or disease Intervention/treatment Phase
Body Fat Disorder Device: The Zeltiq System Not Applicable

Detailed Description:
The purpose of this study is to evaluate the safety and feasibility of a new product under development for non-invasive fat reduction. The new product delivers controlled cooling via a conformable surface applicator, rather than the existing vacuum applicator. A range of treatment parameters will be investigated. At the investigator's discretion, each treatment area may receive up to 3 treatments, spaced 2 - 8 weeks apart. The subjects will return for follow-up at 2 months and 4 months after final treatment. Therefore, the entire study period may last up to 8 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pilot Study of CoolTXT for Non-Invasive Fat Reduction
Study Start Date : February 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
No Intervention: Fat Reduction Device: The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other Names:
  • Cryolipolysis
  • Lipolysis

Primary Outcome Measures :
  1. Efficacy Assessment through Ultrasound Measurements [ Time Frame: 16 weeks post final treatment ]

    The primary endpoint will be analyzed by percent reduction in fat layer thickness, as measured by ultrasound.

    • Safety endpoint: incidence of device- or procedure-related adverse events. Acceptance criteria - zero incidences of UADEs.

Secondary Outcome Measures :
  1. Outcome Measured by Photo Review and Subject Satisfaction Questionnaire [ Time Frame: 16 weeks post final treatment ]
    • Comparison of pre- and 16-week post final treatment photographs of the treatment area(s).
    • Subject satisfaction as assessed by questionnaires administered at 16 weeks post final treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

  • Male or female subjects > 18 years of age and < 65 years of age.
  • Subject has clearly visible fat on intended treatment area(s), which in the investigator's opinion, may benefit from the treatment(s). Treatment areas include: abdomen, saddlebag (outer aspect of upper thighs), upper arms and inner thighs.
  • Subject has not had weight change exceeding 10 pounds in the preceding month.
  • Subject with body mass index (BMI) between 25 and 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 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, abdominoplasty, 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 6 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 in the next 8months.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01517646

Canada, British Columbia
Arbutus Laser Centre
Vancouver, British Columbia, Canada, V6J IZ6
Sponsors and Collaborators
Zeltiq Aesthetics
Principal Investigator: Gerald Boey, MD Arbutus Laser Centre

Responsible Party: Zeltiq Aesthetics Identifier: NCT01517646     History of Changes
Other Study ID Numbers: ZA11-003
First Posted: January 25, 2012    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: January 2012
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zeltiq Aesthetics:
Fat Reduction

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases