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| ID | Type | Description | Link |
|---|---|---|---|
| ZA24-002 | Other Identifier | AbbVie |
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The primary objective of this protocol is the continued collection of data specific to the submental, inner thigh and back/bra body areas with CoolSculpting Elite. The study aims to collect post-market safety data while allowing for the collection of standardized photos and satisfaction questionnaires after treatment with commercial treatment parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: Submental | Other | Participants will receive applications of the CoolSculpting Elite System in the submental body area. |
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| Cohort B: Inner Thigh | Other | Participants will receive applications of the CoolSculpting Elite System in the inner thigh (bilateral) body area. |
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| Cohort C: Back/Bra | Other | Participants will receive applications of the CoolSculpting Elite System in the back/bra (bilateral) body area. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoolSculpting Elite System | Device | CoolSculpting Elite Applicator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Device and/or Procedure-Related Adverse Events (AEs) | Frequency of device and procedure-related AEs including serious device-related adverse events (SADEs), will be analyzed per cohort. | Up to Approximately 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Clinical Innovations | Vista | California | 92083 | United States |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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