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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

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.

Condition or disease Intervention/treatment Phase
Body Fat Disorder Device: CoolSculpting® System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International CoolSculpting: Prospective, Multi-Country, Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)
Estimated Study Start Date : August 31, 2019
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : December 15, 2019

Arm Intervention/treatment
Experimental: CoolSculpting® System
A treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage
Device: CoolSculpting® System
A treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Change in volume of fat from baseline [ Time Frame: Week 12 ]
    Measured for subjects who received 1 treatment.

  8. Change in volume of fat from baseline [ Time Frame: Week 20 ]
    Measured subjects who received 2 treatments

  9. Frequency of AEs including SAEs [ Time Frame: Week 12 ]
    Measured for subjects who received 1 treatment.

  10. Frequency of AEs including SAEs [ Time Frame: Week 20 ]
    Measured subjects who received 2 treatments.

  11. Frequency of ADEs including SADEs [ Time Frame: Week 12 ]
    Measured for subjects who received 1 treatment.

  12. Frequency of ADEs including SADEs [ Time Frame: Week 20 ]
    Measured subjects who received 2 treatments.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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.

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): NCT03909100


Contacts
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Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@Allergan.com

Sponsors and Collaborators
Allergan
Investigators
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Study Director: Matthew Hickling Allergan

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03909100     History of Changes
Other Study ID Numbers: CMO-MA-PLS-0602
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
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
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/

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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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases