Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2026-01-04 @ 4:55 AM
Study NCT ID:
NCT02401334
Status:
COMPLETED
Last Update Posted:
2018-02-15
First Post:
2015-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antimicrobial Hernia Repair Device Clinical Study
Sponsor:
Cook Group Incorporated
Organization:
Study Overview
Official Title:
Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMEX
Brief Summary:
This prospective clinical study will evaluate the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected (i.e., Class II, Class III, and Class IV) surgical fields. Up to 30 patients will be treated with the Cook® Antimicrobial Hernia Repair Device and patients will be followed for 12 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: