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This study is being performed to follow up on subjects who participated in the initial study (ZA10-001) in 2010.
The primary objective of this investigation is to assess the durability of treatment outcomes with the ZELTIQ System.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Zeltiq System | Device | This is a follow-up study from the initial treatments performed in 2010. No additional treatments will be performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Independent Photo Review | The primary effectiveness endpoint is the correct identification of the series of pre-treatment images by the three reviewers. | 12+ mos post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Access reduction | Reduction in the fat layer thickness | 12+ mos post treatment |
| Subject Satisfaction | Subject satisfaction with the Zeltiq procedure as determined by the results of a subjects satisfaction questionnaire at the follow up visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flor Mayoral, MD | Mayoral Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayoral Dermatology | Coral Gables | Florida | 33143 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 5, 2025 | |
| Reset | Jun 23, 2025 | |
| Release | Jul 11, 2025 | |
| Reset | Jul 30, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 5, 2025 | Jun 23, 2025 | |||
| Jul 11, 2025 |
| ID | Term |
|---|---|
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
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| 12+ mos post treatment |
| Jul 30, 2025 |
| D000073319 |
| Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |