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The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This registry will collect data from 100 patients treated for a ventral hernia repair.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with a ventral hernia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intramesh T1 implantation | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate at 12 months determined by clinical examination | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative complications | Defined as complications occurring during index-procedure from "skin-into-skin". The following events must be reported in the case report form:
| peri-procedural |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a ventral hernia
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| Name | Affiliation | Role |
|---|---|---|
| Kurt Van der Speeten, MD, PhD | Ziekenhuis Oost-Limburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | Limburg | 3600 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28438090 | Derived | Wen W, Majerus B, Van De Moortel M, Lobue S, Fobe D, Philippart P, Berwouts L, Coteur J, Gabriels K, Van der Speeten K. Laparoscopic ventral hernia repair using a composite mesh with polypropylene and expanded polytetrafluoroethylene: a prospective, multicentre registry. Acta Chir Belg. 2017 Oct;117(5):295-302. doi: 10.1080/00015458.2017.1313526. Epub 2017 Apr 25. |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D006547 | Hernia |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Post-operative complications | Defined as complications up to 30 days after index-procedure. The following events should be reported in the case report form:
| up to 30 days |
| Seroma | The rate of seroma at 1 month after index-procedure. | 1 month |
| Freedom from hernia-related reinterventions | Reinterventions at 12 months after index-procedure | 12 months |
| Late complications | Late complications at 12 months after index-procedure:
| 12 months |