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The purpose of this study is to capture preliminary clinical safety and performance on the TAHRS
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hernia repair | Experimental | There is no comparator for this study. All patients are in the treatment allocated group for hernia repair with TISSIUMâ„¢ Atraumatic Hernia Repair System (TAHRS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TISSIUMâ„¢ Atraumatic Hernia Repair System (TAHRS) | Device | The TAHRS is intended for fixation of prosthetic material to soft tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Device Effect (SADEs) | Cumulative incidence of complications (CIC) related to the TAHRS including: Infection, Chronic pain, Recurrence of hernia, Impaired/delayed healing at the surgical site(s), Allergic reaction/hypersensitivity reaction, | through 12 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of hernia recurrence through 12 months post- surgery | through 12 months post-surgery |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg [ZOL] | Genk | Limburg | 3600 | Belgium | ||
| Imelda Hospital |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Bonheiden |
| Belgium |
| AZ Sint-Jan | Ruddershove | Belgium |
| CHU UCL Namur | Yvoir | 5530 | Belgium |
| Universitary Hospital Virgen Macarena | Seville | 41009 | Spain |