Non-invasive Fat Reduction
Conditions
Brief summary
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.
Interventions
DEVICECoolSculpting® System
A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Reported Satisfied or Very Satisfied on Cryolipolysis Satisfaction Questionnaire (CSQ) Item #1 Overall | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 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) | 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. |
| Percentage of Participants by Body Mass Index (BMI) Categories Who Reported Satisfied or Very Satisfied on CSQ Item #1 | 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) | 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). |
| Percentage of Participants Who Reported Satisfied or Very Satisfied on CSQ Item #1 in Treated Area(s) | 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) | 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. |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | 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) | 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. |
| Percentage of Participants With Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) | 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) | 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. |
| Change From Baseline in Volume of Fat as Measured by 3 Dimensional (3D) Photography | Baseline to 8 Weeks post-Treatment 1 and 12 Weeks post-Final Treatment 2 | 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). |
Countries
Australia, Canada, Singapore, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CoolSculpting® System 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. | 112 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Deviation | 2 |
| Overall Study | Reason not Specified | 4 |
| Overall Study | Technical Problems | 4 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | CoolSculpting® System |
|---|---|
| Age, Continuous | 42.5 years STANDARD_DEVIATION 9.86 |
| Race/Ethnicity, Customized Arab/Middle Eastern | 1 Participants |
| Race/Ethnicity, Customized Asian - Chinese | 51 Participants |
| Race/Ethnicity, Customized Asian - Korean | 1 Participants |
| Race/Ethnicity, Customized Asian, Other | 9 Participants |
| Race/Ethnicity, Customized Black | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 48 Participants |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 0 / 107 |
| other Total, other adverse events | 10 / 112 | 1 / 107 |
| serious Total, serious adverse events | 0 / 112 | 1 / 107 |
Outcome results
Primary
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.
Time frame: 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)
Population: Evaluable Population included all participants who signed the ICF, had at least 1 of the procedures conducted, and also reported the CSQ Item 1 at 12 weeks after the final treatment (measured at Week 12 for participants who received 1 treatment session and at Week 20 for participants who received 2 treatment sessions).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CoolSculpting® System | Percentage of Participants Who Reported Satisfied or Very Satisfied on Cryolipolysis Satisfaction Questionnaire (CSQ) Item #1 Overall | 89.6 percentage of participants |
Secondary
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).
Time frame: Baseline to 8 Weeks post-Treatment 1 and 12 Weeks post-Final Treatment 2
Population: Evaluable Population included all participants who signed the ICF, had at least 1 of the procedures conducted, and also reported the CSQ Item 1 at 12 weeks after the final treatment (measured at Week 12 for participants who received 1 treatment session and at Week 20 for participants who received 2 treatment sessions). Number analyzed are the number of participants with evaluable data for given category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CoolSculpting® System | Change From Baseline in Volume of Fat as Measured by 3 Dimensional (3D) Photography | Change from Baseline at 8 Weeks Post-Treatment Session 1 | -149.1 mL | Standard Deviation 280.61 |
| CoolSculpting® System | Change From Baseline in Volume of Fat as Measured by 3 Dimensional (3D) Photography | Change from Baseline at 12 Weeks Post-Final Treatment | -264.8 mL | Standard Deviation 411.36 |
Secondary
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).
Time frame: 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)
Population: Evaluable Population included all participants who signed the ICF, had at least 1 of the procedures conducted, and also reported the CSQ Item 1 at 12 weeks after the final treatment (measured at Week 12 for participants who received 1 treatment session and at Week 20 for participants who received 2 treatment sessions). Number analyzed are the number of participants with evaluable data for given category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CoolSculpting® System | Percentage of Participants by Body Mass Index (BMI) Categories Who Reported Satisfied or Very Satisfied on CSQ Item #1 | BMI 18.5 - < 25 | 88.5 percentage of participants |
| CoolSculpting® System | Percentage of Participants by Body Mass Index (BMI) Categories Who Reported Satisfied or Very Satisfied on CSQ Item #1 | BMI 25 - ≤ 30 | 90.7 percentage of participants |
Secondary
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.
Time frame: 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)
Population: Evaluable Population included all participants who signed the ICF, had at least 1 of the procedures conducted, and also reported the CSQ Item 1 at 12 weeks after the final treatment (measured at Week 12 for participants who received 1 treatment session and at Week 20 for participants who received 2 treatment sessions). Number analyzed are the number of participants with evaluable data for given category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 20 Treatment Cycles | 100.0 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 24 Treatment Cycles | 92.2 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 22 Treatment Cycles | 100.0 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 21 Treatment Cycles | 100.0 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 18 Treatment Cycles | 80.0 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 17 Treatment Cycles | 100.0 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 16 Treatment Cycles | 92.3 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 15 Treatment Cycles | 100.0 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 14 Treatment Cycles | 66.7 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 13 Treatment Cycles | 100.0 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 12 Treatment Cycles | 80.0 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 11 Treatment Cycles | 100.0 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 10 Treatment Cycles | 100.0 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 9 Treatment Cycles | 100.0 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 7 Treatment Cycles | 0 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 6 Treatment Cycles | 100.0 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 5 Treatment Cycles | 100.0 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Received 1 or 2 Treatments Who Reported Satisfied or Very Satisfied on CSQ Item #1 by Number of Treatment Cycles | 2 Treatment Cycles | 100.0 percentage of participants |
Secondary
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.
Time frame: 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)
Population: Evaluable Population included all participants who signed the ICF, had at least 1 of the procedures conducted, and also reported the CSQ Item 1 at 12 weeks after the final treatment (measured at Week 12 for participants who received 1 treatment session and at Week 20 for participants who received 2 treatment sessions). Number analyzed are the number of participants with evaluable data for given category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CoolSculpting® System | Percentage of Participants Who Reported Satisfied or Very Satisfied on CSQ Item #1 in Treated Area(s) | Abdomen | 87.1 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Reported Satisfied or Very Satisfied on CSQ Item #1 in Treated Area(s) | Flanks | 93.1 percentage of participants |
| CoolSculpting® System | Percentage of Participants Who Reported Satisfied or Very Satisfied on CSQ Item #1 in Treated Area(s) | Abdomen and Flanks | 89.6 percentage of participants |
Secondary
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.
Time frame: 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)
Population: Safety Population included all participants who had at least 1 of the treatment procedures conducted.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CoolSculpting® System | Percentage of Participants With Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) | ADE | 14.3 percentage of participants |
| CoolSculpting® System | Percentage of Participants With Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) | SADE | 0 percentage of participants |
| CoolSculpting®: Treatment Session 2 | Percentage of Participants With Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) | ADE | 9.3 percentage of participants |
| CoolSculpting®: Treatment Session 2 | Percentage of Participants With Adverse Device Effects (ADEs) and Serious Adverse Device Effects (SADEs) | SADE | 0 percentage of participants |
Secondary
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.
Time frame: 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)
Population: Safety Population included all participants who had at least 1 of the treatment procedures conducted.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CoolSculpting® System | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAE | 14.3 percentage of participants |
| CoolSculpting® System | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAE | 0.0 percentage of participants |
| CoolSculpting®: Treatment Session 2 | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAE | 10.3 percentage of participants |
| CoolSculpting®: Treatment Session 2 | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAE | 0.9 percentage of participants |