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This study aims to generate data that conveys participant's experiences such as their satisfaction with treatment delivered by the redesigned CoolSculpting® Elite system for non-invasive fat reduction in the midsection area (abdomen and flanks) in addition to optional body areas of upper arms, inner thighs, outer thighs and/or submental area. By doing this, the study will provide insights for doctors to better inform participants about the expected outcomes when one or more body areas are considered for treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoolSculpting® Elite System | Experimental | Participants received up to two CoolSculpting® Elite treatment sessions for the abdomen and flanks plus optional additional body areas 8 weeks apart. At the investigator's discretion, per treatment session, up to 8 treatment cycles were performed for the midsection, and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoolSculpting® Elite System with CoolSculpting® Elite applicators | Device | A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With "Satisfied" or "Very Satisfied" on Item #1 for the CSQ (Cryolipolysis Satisfaction Questionnaire) - Midsection | The CSQ-Midsection is a 2-item Patient-reported Outcome (PRO) instrument that measures participant's satisfaction with CoolSculpting® treatment of the midsection (abdomen and flanks). Participants were asked to rate their satisfaction with the results of the fat-reduction procedure on a 5-item scale ranging from Very satisfied to Very dissatisfied. | 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions) |
| Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | An AE will be considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date (and time, if known) of the first dose of study intervention. An AE will be considered a TESAE if it is a TEAE that additionally meets any SAE criterion. TEADE is defined as any TEAE with a reasonable possibility (Possible, Probable, or Causal relationship) that the event may have been caused by the study device. 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 only 1 treatment session and Week 20 + 14 days for those participants who received 2 treatment sessions) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Received Treatment to Abdomen and Flank and One or More Additional Body Areas for Treatment With "Satisfied" or "Very Satisfied" on CSQ-Overall Item 1 | The CSQ-Overall is a 1-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® Elite treatment when midsection and one or more additional body area were selected for treatment. Participants were asked to rate their satisfaction with the results of the fat-reduction procedure when considering the treated areas using a 5-item scale ranging from Very satisfied to Very dissatisfied. |
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Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser & Skin Surgery Medical group, Inc /ID# 239112 | Sacramento | California | 95816-5520 | United States | ||
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| ID | Title | Description |
|---|---|---|
| FG000 | CoolSculpting® Elite System | Participants received up to two CoolSculpting® Elite treatment sessions for the abdomen and flanks plus optional additional body areas 8 weeks apart. At the investigator's discretion, per treatment session, up to 8 treatment cycles were performed for the midsection, and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed).
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| ID | Title | Description |
|---|---|---|
| BG000 | CoolSculpting® Elite System | Participants received up to two CoolSculpting® Elite treatment sessions for the abdomen and flanks plus optional additional body areas 8 weeks apart. At the investigator's discretion, per treatment session, up to 8 treatment cycles were performed for the midsection, and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 With "Satisfied" or "Very Satisfied" on Item #1 for the CSQ (Cryolipolysis Satisfaction Questionnaire) - Midsection | The CSQ-Midsection is a 2-item Patient-reported Outcome (PRO) instrument that measures participant's satisfaction with CoolSculpting® treatment of the midsection (abdomen and flanks). Participants were asked to rate their satisfaction with the results of the fat-reduction procedure on a 5-item scale ranging from Very satisfied to Very dissatisfied. | Evaluable Population 1 consisted of all participants who completed the cryolipolysis treatment plan to the midsection and completed the Cryolipolysis Satisfaction Questionnaire (CSQ)-Midsection Item #1 at 12 weeks after the final treatment session and who do not have any significant protocol deviation or violation. | Posted | Number | 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 participants who received 2 treatment sessions) |
|
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 consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). The data for adverse events is collected and reported per treatment session received. TEAEs occurred on or after the date of treatment session 1 and before the date of treatment session 2 are counted for treatment session 1; TEAEs occurred on or after the date of treatment session 2 are counted for treatment session 2.
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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 Elite: Treatment Session 1 | Participants who received one CoolSculpting® Elite treatment session for the abdomen and flanks plus optional additional body areas. At the investigator's discretion, up to 8 treatment cycles were performed for the midsection and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL TENDERNESS | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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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 | Feb 23, 2021 | Jun 14, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 29, 2022 | Jun 14, 2023 | SAP_001.pdf |
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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 participants who received 2 treatment sessions) |
| Percentage of Participants With "Satisfied" or "Very Satisfied" on Individual Treated Body Areas (Upper Arms, Inner Thighs, Outer Thighs, Fat Under Chin) CSQ Item 1 | The CSQ- Upper Arms, CSQ-Inner Thighs, CSQ-Outer Thighs, CSQ-Fat Under Chin are 1-item Patient-reported Outcome (PRO) instruments that measure participant's satisfaction with CoolSculpting® Elite treatment for the optional additional individual body area(s) treated. Participants were asked to rate their satisfaction with the results of the fat-reduction procedure for the optional additional individual body area(s) treated on a 5-item scale ranging from Very satisfied to Very dissatisfied. | 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who received 2 treatment sessions) |
| Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers | Success was defined as at least 70% correct identification of the pre-treatment images. | 12 weeks after the final treatment session (measured at Week 12 for participants who received 1 treatment session or Week 20 for participants who recieved 2 treatment sessions) |
| Cosmetic Laser Dermatology /ID# 239110 |
| San Diego |
| California |
| 92121-2119 |
| United States |
| Cosmetic Laser Dermatology /ID# 239111 | San Diego | California | 92121-2119 | United States |
| Laser & Skin Surgery Center of New York /ID# 239113 | New York | New York | 10016-4974 | United States |
| Centre Laser International de la Peau /ID# 239117 | Paris | 75007 | France |
| Bodenseeklinik /Id# 239155 | Lindau | 88131 | Germany |
| Halley Medical Aesthetics /ID# 239124 | Singapore | 238858 | Singapore |
| Akademikliniken /ID# 239120 | Stockholm | 115 41 | Sweden |
| Reason not Specified |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Number analyzed is the number of participants at sites in US and Singapore as race and ethnicity were collected only at these sites. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number analyzed is the number of participants at sites in US and Singapore as race and ethnicity were collected only at these sites. | Count of Participants | Participants |
|
| CoolSculpting® Elite System |
Participants received up to two CoolSculpting® Elite treatment sessions for the abdomen and flanks plus optional additional body areas 8 weeks apart. At the investigator's discretion, per treatment session, up to 8 treatment cycles were performed for the midsection, and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs. |
|
|
| Primary | Numbers of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Adverse Device Effects (TEADEs); Treatment Emergent Serious Adverse Events (TESAEs), Serious Adverse Device Effects (SADEs), and Unanticipated TEAEs or ADEs | An AE will be considered a TEAE if the AE began or worsened (increased in severity or became serious) on or after the date (and time, if known) of the first dose of study intervention. An AE will be considered a TESAE if it is a TEAE that additionally meets any SAE criterion. TEADE is defined as any TEAE with a reasonable possibility (Possible, Probable, or Causal relationship) that the event may have been caused by the study device. 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 consisted of all enrolled participants who received at least one cryolipolysis treatment cycle (started or completed). AEs are reported separately for each of the two treatment sessions. | Posted | Count of Participants | Participants | First treatment to Follow-up/Exit Visit (Week 12 + 14 days for those participants who received only 1 treatment session and Week 20 + 14 days for those participants who received 2 treatment sessions) |
|
|
|
| Secondary | Percentage of Participants Who Received Treatment to Abdomen and Flank and One or More Additional Body Areas for Treatment With "Satisfied" or "Very Satisfied" on CSQ-Overall Item 1 | The CSQ-Overall is a 1-item Patient-reported Outcome (PRO) instrument that measures the participant's satisfaction with CoolSculpting® Elite treatment when midsection and one or more additional body area were selected for treatment. Participants were asked to rate their satisfaction with the results of the fat-reduction procedure when considering the treated areas using a 5-item scale ranging from Very satisfied to Very dissatisfied. | Evaluable Population 3 (N=107) consisted of all participants who completed the cryolipolysis treatment plan for any body areas (Midsection, Upper Arms, Inner Thighs, Outer Thighs and Submental Area) and do not have any significant protocol deviation or violation. Overall number analyzed is the number of participants available for analysis for CSQ-Overall Item 1 (n=53). | Posted | Number | 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 participants who received 2 treatment sessions) |
|
|
|
| Secondary | Percentage of Participants With "Satisfied" or "Very Satisfied" on Individual Treated Body Areas (Upper Arms, Inner Thighs, Outer Thighs, Fat Under Chin) CSQ Item 1 | The CSQ- Upper Arms, CSQ-Inner Thighs, CSQ-Outer Thighs, CSQ-Fat Under Chin are 1-item Patient-reported Outcome (PRO) instruments that measure participant's satisfaction with CoolSculpting® Elite treatment for the optional additional individual body area(s) treated. Participants were asked to rate their satisfaction with the results of the fat-reduction procedure for the optional additional individual body area(s) treated on a 5-item scale ranging from Very satisfied to Very dissatisfied. | Evaluable Population consisted of all participants who completed the cryolipolysis treatment plan to one or more additional body areas (Upper Arms, Inner Thighs, Outer Thighs, Submental Area), whether midsection treatment was completed or not, and do not have any significant protocol deviation or violation. Number analyzed for each category is the number of participants with available data for the respective individual body area. | Posted | Number | 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 participants who received 2 treatment sessions) |
|
|
|
| Secondary | Percentage of Participants With Correct Identification of Baseline vs 12-week Post-final Treatment Images of the Treated Body Area(s) by at Least Two Out of Three Blinded, Independent Reviewers | Success was defined as at least 70% correct identification of the pre-treatment images. | Evaluable Population 3 (N=107) consisted of all participants who completed the cryolipolysis treatment plan for any body areas (Midsection, Upper Arms, Inner Thighs, Outer Thighs and Submental Area) and do not have any significant protocol deviation or violation. Overall number analyzed is the number of participants evaluable for any of the body areas. Number analyzed for each category are the number of participants evaluable for the respective individual body area. | Posted | Number | 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 participants who recieved 2 treatment sessions) |
|
|
|
| 0 |
| 110 |
| 0 |
| 110 |
| 5 |
| 110 |
| EG001 | CoolSculpting Elite: Treatment Session 2 | Participants who received a second CoolSculpting® Elite treatment session for the abdomen and flanks plus optional additional body areas. At the investigator's discretion, up to 8 treatment cycles were performed for the midsection and if applicable, up to 2 treatment cycles for the submental area, up to 4 cycles to upper arms, and up to 4 cycles each to inner and/or outer thighs. | 0 | 100 | 0 | 100 | 5 | 100 |
| NAUSEA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| MEDICAL DEVICE PAIN | General disorders | MedDRA 24.0 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| TOOTH INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| HYPOAESTHESIA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Any Unanticipated Treatment-Emergent Adverse Event (UTEAE) |
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| Any Unanticipated Treatment-Emergent Serious Adverse Event (UTESAE) |
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| Any Treatment-Emergent Adverse Device Effect (TEADE) |
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| Any Treatment-Emergent Serious Adverse Device Effect (TESADE) |
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| Any Unanticipated Treatment-Emergent Adverse Device Effect (UTEADE) |
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| Any Unanticipated Treatment-Emergent Serious Adverse Device Effect (UTESADE) |
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| CSQ - Upper Arms |
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| CSQ - Fat Under Chin |
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| Outer Thighs |
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| Upper Arms |
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| Submental Area |
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