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This is a post market prospective, multi-center study of up to 100 subjects undergoing post-mastectomy breast reconstruction (50 Fortiva® 1mm perforated and 50 Fortiva® 1mm non-perforated) at up to 10 clinical study sites in Europe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perforated | Active Comparator | Fortiva® 1mm perforated ADM |
|
| Non-perforated | Active Comparator | Fortiva® 1mm non-perforated ADM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fortiva® 1mm | Device | Post mastectomy immediate reconstruction |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Fortiva® tissue matrix | Safety will be evaluated by assessing the incidence of device and/or procedure related adverse events. | 24 months |
| Performance of Fortiva® tissue matrix | • Analysis of the subject's overall satisfaction with the breast reconstruction procedure will be assessed by obtaining subject's perception of the outcomes using the Breast-QTM - Reconstruction survey. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Agaplesion Markus Krankenhaus | Frankfurt am Main | 60431 | Germany | |||
| Frankfurt University Hospital |
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post market prospective, multi-center study
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| Frankfurt am Main |
| 60590 |
| Germany |
| University Hospital Technical University, Munich | München | 81664 | Germany |
| University Hospital, Ulm | Ulm | 89081 | Germany |
| Guy's Hospital | London | SE1 9RT | United Kingdom |
| Nightingale Breast Unit, Manchester University NHS Foundation Trust (MFT), Wythenshawe Hospital | Manchester | M23 9LT | United Kingdom |