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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 : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics

Brief Summary:
Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the flanks.

Condition or disease Intervention/treatment Phase
Body Fat Disorder Device: The ZELTIQ System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: CoolSculpting the Flanks
Actual Study Start Date : October 25, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: Fat Reduction
The treatments are designed to see if the fat can be reduced in the flanks with a new applicator design.
Device: The ZELTIQ System
The CoolSculpting machine will be used to perform the treatments.




Primary Outcome Measures :
  1. 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

  2. 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.


Secondary Outcome Measures :
  1. Subject survey [ Time Frame: Final post-treatment visit ]
    Subject survey as assessed by questionnaire administered at the final post-treatment visit.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304925


Locations
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United States, California
Innovation Research Center
Pleasanton, California, United States, 94588
Laser & Skin Surgery Center of Northern California
Sacramento, California, United States, 95816
United States, Massachusetts
SkinCare Physicians of Chestnut Hill
Chestnut Hill, Massachusetts, United States, 02467
United States, Minnesota
Zel Skin & Laser Specialist
Edina, Minnesota, United States, 55424
United States, New York
Laser & Skin Surgery Center of New York
New York, New York, United States, 10016
United States, Tennessee
Brian S. Biesman, MD
Nashville, Tennessee, United States, 37203
United States, Texas
EpiCenter Skincare and Laser Center
Dallas, Texas, United States, 95231
Sponsors and Collaborators
Zeltiq Aesthetics
Investigators
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Study Director: Kerrie Jiang, NP Zeltiq Aesthetics

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Responsible Party: Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT03304925     History of Changes
Other Study ID Numbers: ZA17-002
First Posted: October 9, 2017    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases