Status:
TERMINATED
ENDO GIA Stapler With Duet Tissue Reinforcement System (TRS) Used in Pulmonary Resections
Lead Sponsor:
Medtronic - MITG
Conditions:
Lung Disease
Eligibility:
All Genders
20-79 years
Phase:
NA
Brief Summary
The objective of this study is to confirm superiority between a test treatment group using Endo GIA stapler with Duet Tissue Reinforcement System (TRS) and a current international standard of care gro...
Detailed Description
Air leak is a complication of pulmonary surgical procedures that include pulmonary lobectomy, segmentectomy, and bullectomy, reported to occur in 33% to 75% of cases. Prolonged air leak continuing fo...
Eligibility Criteria
Inclusion
- The patient is between 20-79 years of age.
- The patient is eligible to be given pulmonary Lobectomy.
- The patient is scheduled to undergo pulmonary Lobectomy.
- Performance status 0\~1 (Eastern Cooperative Oncology Group classification).
- The patient has no history of lung surgery.
- The patient is healthy organ function.
- The patient is scheduled for surgery with staplers .
- The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.
Exclusion
- The patient has suffered thoracic trauma or has previously undergone pneumonectomy surgery.
- The patient has an active bacterial infection or fungal infection.
- The patient is undergoing continuing systemic administration (intravenous or oral) of steroids.
- The patient condition is complicated by uncontrolled diabetes mellitus.
- The patient participation is judged difficult due to study complications related to a psychiatric disorder or psychological symptoms.
- The patient undergoes surgical procedure other than lobectomy during surgery.
- Reinforcement material other than the study materials are applied during surgery.
- The patient judged unsuitable for study participation by the investigator for any other reason.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01241617
Start Date
August 1 2010
End Date
January 1 2012
Last Update
January 24 2012
Active Locations (1)
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1
Junendo University School of Medicine
Tokyo, Japan