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

Study Overview
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Brief Summary
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This study aims to generate data that conveys participant's 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 participants about the expected outcomes.

Official Title
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International CoolSculpting: Prospective, Multi-Country, Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)

Conditions
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Non-invasive Fat Reduction

Intervention / Treatment
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* Device: CoolSculpting® System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant has clearly visible fat in the flanks and/or abdomen, which in the investigator's opinion, may benefit from the treatment. Participant has not had weight change fluctuations exceeding 4.5 kg (or 5% of body weight) in the preceding month. Participant has a body mass index (BMI) of 18.5 to 30. A BMI is defined as weight in kilograms divided by height in meters squared (kg/m2). Participant 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. Participant agrees to have photographs taken of the treatment area(s) during the scheduled time periods. Exclusion Criteria: Participant has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment. Participant has had a non-invasive fat reduction and/or body contouring procedure in the area(s) of intended treatment within the past 12 months. Participant 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. Participant is pregnant or intending to become pregnant. Participant is lactating or has been lactating in the past 6-9 months. Participant is unable or unwilling to comply with study requirements. Participant 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. Participant has an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant. Participant with known history of cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria. Participant 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). Participant with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol. Participant with impaired peripheral circulation in the area to be treated Participant with neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy. Participant with impaired skin sensation. Participant with open or infected wounds. Participant with bleeding disorders, or concomitant use of blood thinners, or is taking any medication that in the investigator's opinion may increase the participant's risk of bruising. Participant with recent surgery or scar tissue in the area to be treated. Participant has history of hernia in or adjacent to the treatment area(s) site. Participant with skin conditions such as eczema, dermatitis, or rashes in the area to be treated. Participant 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). Participant 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 participant's response or the integrity of the data or would pose an unacceptable risk to the participant. Participant diagnosed with fibrosis.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CoolSculpting® System<br>Participants received up to two CoolSculpting® treatment sessions for the abdomen, flanks or both 8 weeks apart. A treatment session was comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage. Up to 12 cycles per treatment session were performed at the investigator's discretion. | Device: CoolSculpting® System<br>* A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Reported Satisfied or Very Satisfied on Cryolipolysis Satisfaction Questionnaire (CSQ) Item #1 Overall | The CSQ is a 4-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® treatment of the flank, abdomen or both. Participants rated their satisfaction by answering CSQ Item 1=Rate your overall satisfaction with the fat reduction procedure on the treated area using the following scale: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied or Very dissatisfied. | 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Reported Satisfied or Very Satisfied on CSQ Item #1 in Treated Area(s) | The CSQ is a 4-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® treatment of the flank, abdomen or both. Participants rated their satisfaction by answering CSQ Item 1=Rate your overall satisfaction with the fat reduction procedure on the treated area using the following scale: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied or Very dissatisfied. | 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions) | 
| Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | The CSQ is a 4-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® treatment of the flank, abdomen or both. Participants rated their satisfaction by answering CSQ Item 1=Rate your overall satisfaction with the fat reduction procedure on the treated area using the following scale: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied or Very dissatisfied. | 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions) | 
| Percentage of Participants by Body Mass Index (BMI) Categories Who Reported Satisfied or Very Satisfied on CSQ Item #1 | The CSQ is a 4-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® treatment of the flank, abdomen or both. Participants rated their satisfaction by answering CSQ Item 1=Rate your overall satisfaction with the fat reduction procedure on the treated area using the following scale: Very satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied or Very dissatisfied. Participants were analyzed based on BMI ranges from 18.5 to < 25.0 and 25.0 to < 30.0. BMI was defined as weight in kilograms divided by height in meters squared (kg/m^2). | 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for 2 treatment sessions) | 
| Change From Baseline in Volume of Fat as Measured by 3 Dimensional (3D) Photography | Change in the volume of fat was assessed by a 3D stereoscopic camera which was used to generate a 3D image of the body, allowing quantification of the abdomen and flank areas. A 2-step 3D matching algorithm process was used, to identify the change of volume in milliliters (mL). | Baseline to 8 Weeks post-Treatment 1 and 12 Weeks post-Final Treatment 2 | 
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in participants, users, or other persons, if related to the investigational medical device. A SAE is any AE, that is fatal, life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. A TEAE is defined as any new adverse event or worsening of an existing condition after initiation of treatment. | First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments) | 
| Percentage of Participants With Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) | An ADE was defined in accordance with ISO 14155 as an AE related to the use of an investigational medical device or defined as AE with a reasonable possibility (Possible, Probable, or Causal relationship) that the device caused the event. SADE is an ADE that might have led to any SAE consequences if a suitable action had not been taken or intervention had not been made. | First treatment to Follow-up/Exit Visit (Week 12 +/- 14 days for those participants who received 1 treatment and Week 20 +/- 14 days for those participants who received 2 treatments) |