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CoolSculpting and EMS for the Abdomen (ECA)

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: NCT03738891
Recruitment Status : Completed
First Posted : November 13, 2018
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Zeltiq Aesthetics

Tracking Information
First Submitted Date  ICMJE November 8, 2018
First Posted Date  ICMJE November 13, 2018
Last Update Posted Date August 18, 2020
Actual Study Start Date  ICMJE November 7, 2018
Actual Primary Completion Date September 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • Safety endpoint in relation to adverse events [ Time Frame: Final post treatment 1 day visit ]
    Measurement of device- or procedure-related adverse events.
  • Effectiveness endpoint gauged by photographs [ Time Frame: Final post treatment 1 day visit ]
    Comparison of pre-treatment- and 12-week post-final treatment photographs to assess visible changes in the abdomen.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • 3-D imaging [ Time Frame: Final post treatment 1 day visit ]
    Reduction in abdominal circumference as measured by 3-Dimensional imaging.
  • Global Aesthetic Improvement Scale (GAIS) [ Time Frame: Final post treatment 1 day visit ]
    Subject- graded GAIS at 12-week post-final treatment follow-up.
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 and EMS for the Abdomen
Official Title  ICMJE A Feasibility Study to Evaluate Electromagnetic Muscle Stimulation and CoolSculpting for Abdominal Contouring
Brief Summary Evaluate the use of Electromagnetic Muscle Stimulation as an adjunctive treatment to CoolSculpting.
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 abdomen.
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 Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2020)
50
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2018)
60
Actual Study Completion Date  ICMJE September 9, 2019
Actual Primary Completion Date September 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  • Male and female subjects > 22 years of age and ≤65 years of age.
  • Subject has not had weight change exceeding 5% of body weight in the preceding month.
  • Subject agrees to maintain her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
  • Subject agrees to refrain from any new abdominal training exercises during the course of the study.
  • BMI ≤ 30 kg/m2 as determined at screening.
  • Abdominal skin fold thickness 2.0 to 5.0 cm, as measured by caliper below umbilicus.
  • 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, body contouring and/or skin tightening procedure in the area of intended treatment within the past 12 months.
  • Subject has numbness, tingling or other altered sensation in the treatment area.
  • 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 not had an intrauterine contraceptive device inserted or removed 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 has known sensitivity or allergy to isopropyl alcohol and propylene glycol, or latex.
  • 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 a metal implant or active implanted device such as a pacemaker, defibrillator, or drug delivery system.
  • Subject has been involved in any type of abdominal muscle training program within the previous 6 months.
  • Subject has pulmonary insufficiency.
  • Subject has a cardiac disorder.
  • Subject has a malignant tumor.
  • Subject has been diagnosed with epilepsy.
  • Subject currently has a fever.
  • Subject is pregnant or intending to become pregnant during the study period (in the next 9 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 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 NCT03738891
Other Study ID Numbers  ICMJE ZA18-003
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