Status:
TERMINATED
Minimally Invasive Closure of Umbilical Hernias
Lead Sponsor:
South Shore Hospital
Collaborating Sponsors:
Q-Med Scandinavia, Inc.
Conditions:
Umbilical Hernia
Eligibility:
All Genders
1-5 years
Phase:
NA
Brief Summary
The purpose of the study is to test the use of "Deflux" injections in a minimally invasive closure of umbilical (belly button) hernias in infants between birth and five years. The study is designed to...
Detailed Description
All patients will undergo general anesthesia for their primary procedure, i.e. inguinal hernia repair. Once under general anesthesia, the abdomen will be prepped and draped in the usual sterile surgic...
Eligibility Criteria
Inclusion
- Age 1-5 years
- Umbilical hernia\>1cm. diameter.
- Undergoing either a general surgical or urologic procedure under general anesthesia other than umbilical hernia repair.
- No previous umbilical hernia repair.
Exclusion
- Over 5 years
- No umbilical hernia
- No other surgery required
- Previous umbilical hernia repair
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00706329
Start Date
April 1 2008
End Date
March 1 2009
Last Update
November 6 2017
Active Locations (1)
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1
Children's Hospital Boston and South Shore Hospital
South Weymouth, Massachusetts, United States, 02190