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Treatment of Abdomen Study (CMI)

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: NCT02787850
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics

Brief Summary:
Evaluate the safety and efficacy of non-invasive subcutaneous fat layer reduction in the abdomen using an applicator with the Crown Cooling Insert.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: CoolSculpting the Abdomen Using an Applicator With a Crown Cooling Insert
Actual Study Start Date : May 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

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




Primary Outcome Measures :
  1. Blinded independent review of photographs to assess change in visible abdomen fat between baseline (pre-treatment) and 12 weeks post treatment. [ Time Frame: 12 weeks post treatment ]
    The primary efficacy endpoint of the study will be determined by correct identification of baseline (pre-treatment) vs. 12 weeks post-final treatment images by two out of three blinded, independent reviewers. Success will be defined as at least 70% correct identification of the baseline (pre-treatment) photographs.



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 abdomen, which in the investigator's opinion, may benefit from the treatment.
  • Subject is a candidate for a standard CoolSculpting treatment with a CoolMax applicator.
  • No weight change exceeding 5% of body weight in the preceding month.
  • 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, cold agglutinin disease 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 or any other metal containing implant.
  • Subject is pregnant or intending to become pregnant during the study period (in the next 5 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.
  • Subject is prone to severe claustrophobia (during MRI scans).
  • 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): NCT02787850


Locations
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United States, Florida
Bowes Dermatology Group
Miami, Florida, United States, 33133
Sponsors and Collaborators
Zeltiq Aesthetics
Investigators
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Principal Investigator: Leyda Bowes, MD Bowes Dermatology Group
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Responsible Party: Zeltiq Aesthetics
ClinicalTrials.gov Identifier: NCT02787850    
Other Study ID Numbers: ZA16-002
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases