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CoolSculpting the Flanks (CSI)

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.
 
ClinicalTrials.gov Identifier: NCT03304925
Recruitment Status : Active, not recruiting
First Posted : October 9, 2017
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics

Tracking Information
First Submitted Date  ICMJE October 3, 2017
First Posted Date  ICMJE October 9, 2017
Last Update Posted Date August 18, 2020
Actual Study Start Date  ICMJE October 25, 2017
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2017)
  • Safety endpoint in relation to adverse events [ Time Frame: Final post treatment visit ]
    Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs
  • Effectiveness endpoint gauged by reduction in fat layer thickness [ Time Frame: Final post-treatment visit ]
    Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.
Original Primary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
  • Safety endpoint [ Time Frame: Final post treatment visit ]
    Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs
  • Effectiveness endpoint [ Time Frame: Final post-treatment visit ]
    Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2017)
  • Subject survey [ Time Frame: Final post-treatment visit ]
    Subject survey as assessed by questionnaire administered at the final post-treatment visit.
  • Photo review [ Time Frame: Final post-treatment visit ]
    Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CoolSculpting the Flanks
Official Title  ICMJE CoolSculpting the Flanks
Brief Summary Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flanks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Body Fat Disorder
Intervention  ICMJE Device: The ZELTIQ System
The CoolSculpting machine will be used to perform the treatments.
Study Arms  ICMJE Experimental: Fat Reduction
The treatments are designed to see if the fat can be reduced in the flanks with a new applicator design.
Intervention: Device: The ZELTIQ System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 3, 2017)
320
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Male or female subjects > 22 years of age and < 65 years of age.
  • Subject has clearly visible fat on the flanks, which in the investigator's opinion, may benefit from the treatment.
  • No weight change exceeding 5% of body weight 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%) by not making any major changes in their diet or exercise routine during the course of the study.
  • Subject has read and signed the study 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 12 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 during the study period (in the next 8 months).
  • Subject is lactating or has been lactating in the past 6 months.
  • Subject has a history of hernia in the areas to be treated.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03304925
Other Study ID Numbers  ICMJE ZA17-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zeltiq Aesthetics
Study Sponsor  ICMJE Zeltiq Aesthetics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kerrie Jiang, NP Zeltiq Aesthetics
PRS Account Zeltiq Aesthetics
Verification Date August 2020

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