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The objective of this study is to determine the safety and effectiveness of the IDEAL IMPLANT in women who are undergoing primary breast augmentation or replacement of existing saline-filled or silicone gel-filled augmentation implants.
For complete information about the clinical trial, see link in the reference section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| breast augmentation | Experimental | breast implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline-filled breast implant [IDEAL IMPLANT (R)] | Device | Breast augmentation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the safety and effectiveness of the IDEAL IMPLANT in women who are undergoing primary breast augmentation or replacement of existing saline-filled or silicone gel-filled augmentation implants. | 2 mo, 6 mo, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 yrs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beverly Hills | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29489559 | Derived | Nichter LS, Hardesty RA, Anigian GM. IDEAL IMPLANT Structured Breast Implants: Core Study Results at 6 Years. Plast Reconstr Surg. 2018 Jul;142(1):66-75. doi: 10.1097/PRS.0000000000004460. |
| Label | URL |
|---|---|
| Click here for more information about study: "Core Study of the Safety and Effectiveness of IDEAL IMPLANT(R) Saline-filled Breast Implants | View source |
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| Folsom |
| California |
| United States |
| Huntington Beach | California | United States |
| Modesto | California | United States |
| Riverside | California | United States |
| Sacramento | California | United States |
| Santa Monica | California | United States |
| Stockton | California | United States |
| Boca Raton | Florida | United States |
| Boynton Beach | Florida | United States |
| Fort Lauderdale | Florida | United States |
| Hollywood | Florida | United States |
| Jacksonville | Florida | United States |
| Loxahatchee Groves | Florida | United States |
| Miami | Florida | United States |
| Ponte Vedra Beach | Florida | United States |
| Duluth | Georgia | United States |
| Marietta | Georgia | United States |
| Roswell | Georgia | United States |
| Allen | Texas | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| Irving | Texas | United States |
| Southlake | Texas | United States |