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

January 9, 2013
September 27, 2013
January 2013
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01767142 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Feasibility Study of a Belt Applicator
Feasibility Study of a Belt Applicator for Non-Invasive Fat Reduction in the Outer Thigh

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Body Fat Disorder
Device: The Zeltiq System
Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
Other Names:
  • Cryolipolysis
  • Lipolysis
Experimental: Fat Reduction
Intervention: Device: The Zeltiq System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01767142
ZA12-009
No
Zeltiq Aesthetics
Zeltiq Aesthetics
Not Provided
Not Provided
Zeltiq Aesthetics
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP