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| Name | Class |
|---|---|
| Medtronic - MITG | INDUSTRY |
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This study is being done to test the efficacy of Symbotexâ„¢ as an effective synthetic mesh option in the repair of grade I and II ventral hernias.
This study is being done to validate the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias. It will also set the groundwork for a future clinical trial in which the efficacy of Symbotex® can be compared to other synthetic mesh products on the market.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbotexâ„¢ Composite Mesh | Device | Repair of a Grade I or II ventral hernia according to VHWG classification system with Symbotexâ„¢ Composite Mesh |
| Measure | Description | Time Frame |
|---|---|---|
| Hernia Recurrence | One year | |
| Quality of Life | One year | |
| Hernia associated pain and movement limitations pre-surgery compared to post-surgery | One year | |
| Reoperation Rate | One year | |
| Percutaneous Intervention Rate | One year | |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability" | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Park, M.D. | Anne Arundel Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20304452 | Background | Ventral Hernia Working Group; Breuing K, Butler CE, Ferzoco S, Franz M, Hultman CS, Kilbridge JF, Rosen M, Silverman RP, Vargo D. Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery. 2010 Sep;148(3):544-58. doi: 10.1016/j.surg.2010.01.008. Epub 2010 Mar 20. | |
| 14501505 |
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| Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Ann Surg. 2003 Sep;238(3):391-9; discussion 399-400. doi: 10.1097/01.sla.0000086662.49499.ab. |
| Background | SymbotexTM clinging effect observed during the design validation conducted by Covidien in porcine model in May 2013- covidien internal memorandum 0901CR261a (July 2013) |
| Background | Malangoni MA and Rosen MJ. Chapter 46: Hernias, Sabiston Textbook of Surgery 19th Edition. Elsevier; Philadelphia, PA. 2012: 1128-1135 |
| 18387468 | Background | Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW. Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg. 2008 Apr;206(4):638-44. doi: 10.1016/j.jamcollsurg.2007.11.025. Epub 2008 Feb 1. |
| 20404280 | Background | Itani KM, Hur K, Kim LT, Anthony T, Berger DH, Reda D, Neumayer L; Veterans Affairs Ventral Incisional Hernia Investigators. Comparison of laparoscopic and open repair with mesh for the treatment of ventral incisional hernia: a randomized trial. Arch Surg. 2010 Apr;145(4):322-8; discussion 328. doi: 10.1001/archsurg.2010.18. |
| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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