Status:
TERMINATED
SEMPERFLO* Pain Management System in Inguinal Hernia Repair
Lead Sponsor:
Ethicon, Inc.
Conditions:
Inguinal Hernia
Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will compare the clinical performance of the SEMPERFLO\* Pain Management System with another commercial pain relief system using 0.5% bupivacaine following unilateral, open, inguinal hernia...
Detailed Description
Pain will be evaluated up to 5 days after surgery Subjects will be followed for 30 days after surgery.
Eligibility Criteria
Inclusion
- Subject is a candidate for primary, non-emergent unilateral, open inguinal hernia repair procedure
- Subject is 18 years or older
- Subject must be willing to participate in the study, and provide informed consent to participate.
Exclusion
- Subjects undergoing recurrent hernia repair;
- Subjects who plan to undergo another elective surgical procedure prior to the completion of this study;
- Subjects with known allergy to bupivacaine;
- Subjects with immunodeficiency diseases (including known HIV);
- Subjects with any findings identified by the surgeon that may preclude conduct of the study;
- Subjects who are known current alcohol and/or drug abusers;
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00423241
Start Date
January 1 2007
End Date
January 1 2008
Last Update
August 23 2010
Active Locations (6)
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1
Boca Raton Community Hospital
Boca Raton, Florida, United States
2
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
3
Washington University
St Louis, Missouri, United States
4
Universtiy of Tennessee
Knoxville, Tennessee, United States