The objectives of this clinical trial are the overall performance and safety of the ENDO GIA Staplers with ENDO GIA SULUs with Duet TRS TM.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS.
Duke University Health System
Durham, North Carolina, United States
Incidence of Adverse Events.
Time frame: Day 30
Operating Room (OR) Time
OR time was captured in minutes, with time starting at the first port placement and concluding at the removal of the last port.
Time frame: Day 0
Length of Hospital Stay
Days spent in the hospital
Time frame: Day 2 (Approximately 1.5 days post randomization)
Incidence of Stapler 'Misfires'
The incidence of stapler misfires was captured as the number of patients with misfires. The types of misfires that were captured were less than B shaped staples, incomplete staple line and stripping of the rack teeth.
Time frame: Day 0
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