ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection
The objectives of this clinical trial are to compare the incidence and duration of air leaks and the incidence of prolonged air leaks (defined as > 5 days by the Society for Thoracic Surgery) when using the ENDO GIA™ Stapler with ENDO GIA™ SULU with TRI-STAPLE™ Technology in a pulmonary resection via Video Assisted Thoracoscopic Surgery (VATS).
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Multi-Center Evaluation of the ENDO GIA™ Stapler With ENDO GIA™ Reload With Tri-Staple™ Technology in a Pulmonary Resection|
- Incidence of Prolonged Air Leaks [ Time Frame: Day 30 ] [ Designated as safety issue: No ]Defined as > 5 days by the Society for Thoracic Surgery
- Incidence of Air Leaks [ Time Frame: Day 30 ] [ Designated as safety issue: No ]As recorded on the air leak log.
- Duration of Air Leak [ Time Frame: Day 30 ] [ Designated as safety issue: No ]Measured in days. For patients discharged from the hospital with a Heimlich valve, the duration will be censored on the date of discharge.
- Length of Hospital Stay [ Time Frame: Approximately Day 6 ] [ Designated as safety issue: No ]
- Duration of Chest Tube Following Surgery [ Time Frame: Approximately Day 5 ] [ Designated as safety issue: No ]Chest tube duration was calculated as removal date - placement date + 1
- Incidence of Serosal Tearing [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
|Study Start Date:||November 2010|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: ENDO GIA™ Stapler with TRI-STAPLE™ Technology
Single arm study, all patients will receive the study device.
Device: ENDO GIA™ Stapler with TRI-STAPLE™ Technology
All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241565
|United States, California|
|Cedar Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|United States, Illinois|
|Advocate Christ Medical Center|
|Oak Lawn, Illinois, United States, 60453|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Robert McKenna, MD||Cedar Sinai Medical Center|