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A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.

Incisional Hernia Clinical Trial

Official title:
A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.

Clinical Trial Summary

Single-arm study of Phasix Mesh in High Risk patients looking at SSI and recurrence rates.

Clinical Trial Description

The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ Mesh in subjects requiring primary ventral, incisional or first-recurrent (protocol version 1.4)/multiply-recurrent (protocol version 2.0) hernia repair in subjects at high risk for complications. Subjects at high risk are defined as having 1 or more of the following co-morbidity conditions: body mass index (BMI) between 30-40 kg/m2, inclusive, active smokers, chronic obstructive pulmonary disease (COPD), diabetes, immunosuppression, coronary artery disease, chronic corticosteroid use, low pre-operative serum albumin, advanced age, or renal insufficiency. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01961687
Study type Interventional
Source C. R. Bard
Contact
Status Completed
Phase N/A
Start date September 2013
Completion date January 27, 2020
View Details
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