Status:
COMPLETED
A Retrospective Study With Prospective Follow-Up of Complex Ventral Hernia Repair Utilizing the AlloMax Surgical Graft
Lead Sponsor:
C. R. Bard
Conditions:
Hernia
Eligibility:
All Genders
18+ years
Brief Summary
This study will enroll subjects who underwent a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past. All subjects who underwent a ventral hernia repair using the Allo...
Detailed Description
Study protocol was amended in June of 2011 to exclude further enrollment of subjects who underwent ventral hernia repair with the AlloMax Surgical Graft to bridge hernia defects.
Eligibility Criteria
Inclusion
- Have undergone a ventral hernia repair using the AlloMax Surgical Graft at least 9 months in the past. (June 2011 protocol amendment further specified inclusion of subjects who have undergone a non-bridging hernia repair.)
- Have signed an informed consent form (ICF).
Exclusion
- Underwent implantation of the AlloMax Surgical Graft for any reason other than ventral hernia repair.
- June 2011 protocol amendment added: used AlloMax Surgical Graft to bridge a defect.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01205399
Start Date
September 1 2010
End Date
October 1 2011
Last Update
January 18 2017
Active Locations (5)
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1
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
2
Benrus Surgical Associates, Inc
City of Saint Peters, Missouri, United States, 63376
3
Winthrop Surgical Associates, Inc.
Mineola, New York, United States, 11501
4
Surgical Associates, Inc.
Tulsa, Oklahoma, United States, 74136