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A Prospective Trial of a Bio-absorbable Mesh in Challenging Laparoscopic Ventral or Incisional Hernia Repair — ATLAS  

Incisional Hernia Clinical Trial

Official title:
A Prospective, Multi-center Trial of a Long-term Bio-Absorbable Mesh With Sepra Technology in Challenging Laparoscopic Ventral or Incisional Hernia Repair

Clinical Trial Summary

The objective of this study is to collect additional data on safety, performance and effectiveness of Phasix™ ST in subjects receiving laparoscopic ventral or incisional hernia repair at high risk for surgical site occurrence (SSO).

Clinical Trial Description

Subjects at high risk are defined as having 1 or more of the following co-morbid 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 NCT02712398
Study type Interventional
Source C. R. Bard
Contact
Status Completed
Phase N/A
Start date April 2016
Completion date November 15, 2019
View Details
See also
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