Pilot Study of CoolTXT for Non-Invasive Fat Reduction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Zeltiq Aesthetics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics
ClinicalTrials.gov Identifier:
NCT01517646
First received: January 4, 2012
Last updated: September 12, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention
Body Fat Disorder
Device: The Zeltiq System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Pilot Study of CoolTXT for Non-Invasive Fat Reduction

Resource links provided by NLM:


Further study details as provided by Zeltiq Aesthetics:

Primary Outcome Measures:
  • Efficacy Assessment through Ultrasound Measurements [ Time Frame: 16 weeks post final treatment ] [ Designated as safety issue: No ]

    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:
  • Outcome Measured by Photo Review and Subject Satisfaction Questionnaire [ Time Frame: 16 weeks post final treatment ] [ Designated as safety issue: No ]
    • 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.


Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01517646

Locations
Canada, British Columbia
Arbutus Laser Centre
Vancouver, British Columbia, Canada, V6J IZ6
Sponsors and Collaborators
Zeltiq Aesthetics
  More Information

No publications provided

Responsible Party: Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT01517646     History of Changes
Other Study ID Numbers: ZA11-003
Study First Received: January 4, 2012
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Zeltiq Aesthetics:
Lipolysis
Cryolipolysis
Fat Reduction

Additional relevant MeSH terms:
Sphingolipidoses
Lipid Metabolism Disorders
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on September 22, 2014