The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
This is a single arm study.
Clarian Bariatric Center/Indiana University
Indianapolis, Indiana, United States
Proportion of Patients With an Uneventful Creation of a Functional Staple Line
Time frame: Day 0
Incidence of Intra-operative Bleeding Requiring Intervention
Time frame: Day 0 and 1 month
Length of Hospital Stay
Time frame: Date of discharge which averages 3 days
Incidence of Serosal Tearing
Time frame: 30 days post op
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