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Non-Invasive Reduction of Fat in the Inner Thighs

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics
ClinicalTrials.gov Identifier:
NCT01517659
First received: January 17, 2012
Last updated: January 4, 2013
Last verified: November 2012
History of Changes

January 17, 2012
January 4, 2013
November 2012
June 2013   (final data collection date for primary outcome measure)
Efficacy and Safety [ Time Frame: 16 weeks post treatment ] [ Designated as safety issue: No ]
  • Efficacy endpoint: correct identification of pre-treatment vs. 16-week post-treatment images by three masked independent reviewers. Success will be defined as at least 80% correct identification of the pre-treatment images.
  • Safety endpoint: measurement of device- or procedure-related adverse events.
Efficacy of fat reduction in the inner thigh [ Time Frame: 16 weeks post treatment ] [ Designated as safety issue: No ]
  • Changes in the contour of the inner thigh as established by blinded photographic review of a series of pre- and 16-week post-treatment images for each subject.
  • Ultrasound measurements to assess changes in fat layer thickness in the inner thigh at baseline vs. 16 weeks post-treatment.
  • Tape measurements of changes in the circumference of the treated leg at baseline vs. 16 weeks post-treatment.
  • Subject's assessment of change in fit of clothing in the treated area.
Complete list of historical versions of study NCT01517659 on ClinicalTrials.gov Archive Site
Subject Satisfaction [ Time Frame: 16 weeks post final treatment ] [ Designated as safety issue: No ]
Subject satisfaction as assessed by questionnaires administered at 16 weeks post-treatment.
Secondary Outcome Measured through Safety Data and Subject Satisfaction [ Time Frame: 16 weeks post final treatment ] [ Designated as safety issue: No ]

Safety will be assessed by the incidence of device- or procedure-related adverse events.

The number and percentage of subjects will be summarized for each possible point grade of the subject satisfaction questionnaire at 16 weeks.
Not Provided
Not Provided
 
Non-Invasive Reduction of Fat in the Inner Thighs
Non-Invasive Reduction of Fat in the Inner Thighs With the Zeltiq Coolsculpting System

Evaluate the safety and efficacy of non-invasive fat reduction in the inner thighs with the ZELTIQ CoolSculpting System.
Not Provided
Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
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
No Intervention: 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
20
September 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria

  1. Male or female subjects > 18 years of age and < 65 years of age.
  2. Subject has clearly visible fat on the inner thighs and in the investigator's opinion, may benefit from the treatment.
  3. Subject has not had weight change exceeding 10 pounds in the preceding month.
  4. 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.]
  5. 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.
  6. Subject has read and signed a written informed consent form.

Exclusion Criteria

  1. Subject has had a surgical procedure(s) in the area of intended treatment.
  2. Subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment.
  3. Subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months.
  4. Subject needs to administer, or has a known history of, subcutaneous injections (e.g., heparin, insulin) into the area of intended treatment within the past month.
  5. Subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria.
  6. 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.
  7. Subject has a history of a bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
  8. Subject is taking or has taken diet pills or supplements within the past month.
  9. 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).
  10. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system
  11. Subject is pregnant or intends to become pregnant in the next 8 months.
  12. Subject is lactating or has been lactating in the past 6 months.
  13. Subject is unable or unwilling to comply with the study requirements.
  14. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
  15. 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
 
NCT01517659
ZA12-002
No
Zeltiq Aesthetics
Zeltiq Aesthetics
Not Provided
Not Provided
Zeltiq Aesthetics
November 2012

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