Status:
UNKNOWN
Study of Paraesophageal Hernia Repair With Small Intestine Submucosa
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Cook Biotech Incorporated
Washington University School of Medicine
Conditions:
Hiatal Hernia
Paraesophageal Hernia
Eligibility:
All Genders
18+ years
Brief Summary
In 2006 this research group reported their initial findings of a multi-center prospective trial comparing primary repair and primary repair buttressed with a biologic mesh made from porcine small inte...
Detailed Description
Traditionally paraesophageal hernias were repaired by thoracotomy or laparotomy with morbidity around 20% and mortality of 2%.1,2 The advent and later popularization of antireflux operations via the m...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Prior enrollment in Phase I study.
- Exclusion criteria:
- None.
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00786084
Start Date
September 1 2008
End Date
December 1 2009
Last Update
October 1 2009
Active Locations (4)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
2
Oregon Health & Science University
Portland, Oregon, United States, 92701-3098
3
The Oregon Clinic, PC
Portland, Oregon, United States, 97227-1655
4
University of Washington
Seattle, Washington, United States, 98105