Feasibility Study of a Belt Applicator

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics
ClinicalTrials.gov Identifier:
NCT01767142
First received: January 9, 2013
Last updated: September 27, 2013
Last verified: January 2013
  Purpose

Evaluate the safety and feasibility of non-invasive fat reduction in the outer thigh with a belt applicator. Applicator design and treatment parameters will be evaluated.


Condition Intervention
Body Fat Disorder
Device: The Zeltiq System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Feasibility Study of a Belt Applicator for Non-Invasive Fat Reduction in the Outer Thigh

Resource links provided by NLM:


Further study details as provided by Zeltiq Aesthetics:

Primary Outcome Measures:
  • Effectiveness [ Time Frame: 16 weeks post final treatment ] [ Designated as safety issue: No ]
    Effectiveness endpoint: percent reduction in fat layer thickness, as measured by ultrasound.


Secondary Outcome Measures:
  • Photographs pre and 16-week post [ Time Frame: 16 weeks post final treatment ] [ Designated as safety issue: No ]
    Comparison of pre- and 16-week post treatment photographs of the treatment area(s) for discernible reduction in treatment area(s).

  • Subject Satisfaction [ Time Frame: 16 weeks post treatment ] [ Designated as safety issue: No ]
    Subject satisfaction as assessed by questionnaires administered at 16 weeks post treatment.


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

  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 (outer thighs), which in the investigator's opinion, may benefit from the treatment(s).
  • 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 his/her 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 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 8 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.
  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: NCT01767142

Locations
United States, California
Marina Plastic Surgery
Marina del Rey, California, United States, 90292
Innovation Research Center
Pleasanton, California, United States, 94588
Sponsors and Collaborators
Zeltiq Aesthetics
  More Information

No publications provided

Responsible Party: Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT01767142     History of Changes
Other Study ID Numbers: ZA12-009
Study First Received: January 9, 2013
Last Updated: September 27, 2013
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 18, 2014