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International CoolSculpting: Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)

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ClinicalTrials.gov Identifier: NCT03909100
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE March 18, 2019
First Posted Date  ICMJE April 9, 2019
Last Update Posted Date August 16, 2019
Estimated Study Start Date  ICMJE August 31, 2019
Estimated Primary Completion Date December 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
  • Proportion of subjects with "satisfied" or "very satisfied" on CSQ Item #1 [ Time Frame: Week 12 ]
    Measured for subjects who received 1 treatment. The CSQ is a 4-item PRO instrument that measures patient satisfaction with CoolSculpting treatment of the flank and abdomen. The questionnaire will assess overall patient satisfaction with treatment, visible fat reduction, improvement in fit of clothing, and overall effect of treatment.
  • Proportion of subjects with "satisfied" or "very satisfied" on CSQ Item #1 [ Time Frame: Week 20 ]
    Measured for subjects who received 1 treatment. The CSQ is a 4-item PRO instrument that measures patient satisfaction with CoolSculpting treatment of the flank and abdomen. The questionnaire will assess overall patient satisfaction with treatment, visible fat reduction, improvement in fit of clothing, and overall effect of treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03909100 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
  • Proportion of subjects with "satisfied" or "very satisfied" on CSQ Item #1 [ Time Frame: Week 12 ]
    Measured for subjects who received 1 treatment. The CSQ is a 4-item PRO instrument that measures patient satisfaction with CoolSculpting treatment of the flank and abdomen. The questionnaire assesses patient satisfaction with treatment, visible fat reduction, improvement in fit of clothing, and overall effect of treatment.
  • Proportion of subjects with "satisfied" or "very satisfied" on CSQ Item #1 [ Time Frame: Week 20 ]
    Measured for subjects who received 2 treatments. The CSQ is a 4-item PRO instrument that measures patient satisfaction with CoolSculpting treatment of the flank and abdomen. The questionnaire assesses patient satisfaction with treatment, visible fat reduction, improvement in fit of clothing, and overall effect of treatment.
  • Proportion of subjects by number of treatment cycles who received 1 or 2 treatments with "satisfied" or "very satisfied" on CSQ item #1 [ Time Frame: Week 12 ]
    Measured for subjects who received 1 treatment. The CSQ is a 4-item PRO instrument that measures patient satisfaction with CoolSculpting treatment of the flank and abdomen. The questionnaire assesses patient satisfaction with treatment, visible fat reduction, improvement in fit of clothing, and overall effect of treatment.
  • Proportion of subjects by number of treatment cycles who received 1 or 2 treatments with "satisfied" or "very satisfied" on CSQ item #1 [ Time Frame: Week 20 ]
    Measured for subjects who received 2 treatments. The CSQ is a 4-item PRO instrument that measures patient satisfaction with CoolSculpting treatment of the flank and abdomen. The questionnaire assesses patient satisfaction with treatment, visible fat reduction, improvement in fit of clothing, and overall effect of treatment.
  • Proportion of subjects by BMI categories with "Satisfied" or "Very Satisfied" on CSQ Item #1 [ Time Frame: Week 12 ]
    Measured for subjects who received 1 treatment. The CSQ is a 4-item PRO instrument that measures patient satisfaction with CoolSculpting treatment of the flank and abdomen. The questionnaire assesses patient satisfaction with treatment, visible fat reduction, improvement in fit of clothing, and overall effect of treatment.
  • Proportion of subjects by BMI categories with "Satisfied" or "Very Satisfied" on CSQ Item #1 [ Time Frame: Week 20 ]
    Measured for subjects who received 2 treatments. The CSQ is a 4-item PRO instrument that measures patient satisfaction with CoolSculpting treatment of the flank and abdomen. The questionnaire assesses patient satisfaction with treatment, visible fat reduction, improvement in fit of clothing, and overall effect of treatment.
  • Change in volume of fat from baseline [ Time Frame: Week 12 ]
    Measured for subjects who received 1 treatment.
  • Change in volume of fat from baseline [ Time Frame: Week 20 ]
    Measured subjects who received 2 treatments
  • Frequency of AEs including SAEs [ Time Frame: Week 12 ]
    Measured for subjects who received 1 treatment.
  • Frequency of AEs including SAEs [ Time Frame: Week 20 ]
    Measured subjects who received 2 treatments.
  • Frequency of ADEs including SADEs [ Time Frame: Week 12 ]
    Measured for subjects who received 1 treatment.
  • Frequency of ADEs including SADEs [ Time Frame: Week 20 ]
    Measured subjects who received 2 treatments.
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 International CoolSculpting: Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)
Official Title  ICMJE International CoolSculpting: Prospective, Multi-Country, Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)
Brief Summary This study aims to generate data that conveys subjects' experiences such as their overall satisfaction with the CoolSculpting treatment for their belly and love handles. By doing this, the study will provide insights for doctors to better inform subjects about the expected outcomes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Body Fat Disorder
Intervention  ICMJE Device: CoolSculpting® System
A treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage
Study Arms  ICMJE Experimental: CoolSculpting® System
A treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage
Intervention: Device: CoolSculpting® 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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 8, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2019
Estimated Primary Completion Date December 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject has clearly visible fat in the flanks and/or abdomen, which in the investigator's opinion, may benefit from the treatment.
  • Subject has not had weight change fluctuations exceeding 4.5 kg (or 5% of body weight) in the preceding month.
  • Subject has a BMI of 18.5 to 30. A BMI is defined as weight in kilograms divided by height in meters squared (kg/m2).
  • Subject agrees to maintain weight (ie, within 5% of body weight) by not making any changes in diet or exercise routine during the course of the study.
  • Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.

Exclusion Criteria:

  • Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment.
  • Subject has had a non-invasive fat reduction and/or body contouring procedure in the area(s) of intended treatment within the past 12 months.
  • Subject needs to administer, or has a known history of subcutaneous injections into the area(s) of intended treatment (eg, cortisone, heparin, insulin) within the past 6 months.
  • Subject is pregnant or intending to become pregnant.
  • Subject is lactating or has been lactating in the past 6-9 months.
  • Subject is unable or unwilling to comply with study requirements.
  • Subject is currently enrolled in a clinical study of any unapproved investigational device, investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant.
  • Subject with known history of cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.
  • Subject with known sensitivity to cold or has any condition with a known response to cold exposure that limits blood flow to the skin such as cold urticaria or Raynaud's disease, or Chilblains (pernio).
  • Subject with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol.
  • Subject with impaired peripheral circulation in the area to be treated
  • Subject with neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy.
  • Subject with impaired skin sensation.
  • Subject with open or infected wounds.
  • Subject with bleeding disorders, or concomitant use of blood thinners, or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.
  • Subject with recent surgery or scar tissue in the area to be treated.
  • Subject has history of hernia in or adjacent to the treatment area(s) site.
  • Subject with skin conditions such as eczema, dermatitis, or rashes in the area to be treated.
  • 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 is taking or has taken diet pills or supplements within the past 6 months.
  • 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.
  • Subject diagnosed with fibrosis.
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: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@Allergan.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03909100
Other Study ID Numbers  ICMJE CMO-MA-PLS-0602
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Supporting Materials: Study Protocol
Supporting Materials: Clinical Study Report (CSR)
Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: http://www.allerganclinicaltrials.com/
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Matthew Hickling Allergan
PRS Account Allergan
Verification Date August 2019

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