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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoolSculpting® System | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoolSculpting® System | Device | A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage. |
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| 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) |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Jo | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sandhurt Plastic Surgery | Bendigo | Victoria | 3550 | Australia | ||
| Academy Face and Body |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 20, 2019 | Jun 8, 2023 |
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| 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) |
| Subiaco |
| Western Australia |
| 6008 |
| Australia |
| Vancouver Laser & Skin Care Centre | Vancouver | British Columbia | V5Z 1H2 | Canada |
| Halley Medical Aesthetics | Singapore | 238858 | Singapore |
| Dr Benjamin Yim Clinical Aesthetics and Laser Centre | Singapore | 238884 | Singapore |
| Revere Riverside Ltd | Northwood | Middlesex | HA6 2NP | United Kingdom |
| Revere Clinics | London | W1G 7JA | United Kingdom |
| Safety Population | All participants who had at least 1 of the treatment procedures conducted. |
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| Received Treatment in Session 2 |
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| Evaluable Population | Evaluable Population included all participants who signed the informed consent form (ICF), had at least 1 of the procedures conducted, and also reported the Cryolipolysis Satisfaction Questionnaire (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). |
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| COMPLETED |
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| NOT COMPLETED |
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Safety Population included all participants who had at least 1 of the treatment procedures conducted.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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). | Posted | Number | 95% Confidence Interval | percentage of participants | 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) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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) |
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| 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). | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | 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) |
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| 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). | 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. | Posted | Mean | Standard Deviation | mL | Baseline to 8 Weeks post-Treatment 1 and 12 Weeks post-Final Treatment 2 |
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| 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. | Safety Population included all participants who had at least 1 of the treatment procedures conducted. | Posted | Number | percentage of participants | 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) |
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| 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. | Safety Population included all participants who had at least 1 of the treatment procedures conducted. | Posted | Number | percentage of participants | 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) |
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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)
Safety Population included all participants who had at least 1 of the treatment procedures conducted. AEs are reported separately for each of the two treatment sessions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CoolSculpting®: Treatment Session 1 | Participants who received one CoolSculpting® treatment session for the abdomen, flanks or both. 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. | 0 | 112 | 0 | 112 | 10 | 112 |
| EG001 | CoolSculpting®: Treatment Session 2 | Participants who received a second CoolSculpting® treatment session for the abdomen, flanks or both 8 weeks after the first session. 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. | 0 | 107 | 1 | 107 | 1 | 107 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 22.0 | Systematic Assessment | Number of participants at risk are female participants as this adverse event is specific to females. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2018 | Feb 26, 2021 | SAP_001.pdf |
| Asian - Chinese |
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| Asian - Korean |
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| Asian, Other |
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| Arab/Middle Eastern |
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| Other |
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