The purpose of this study is to prospectively generate device-specific clinical data related to the performance of Echelon Contour per its instructions for use (IFU).
Study Type
OBSERVATIONAL
Enrollment
9
There is no intervention, beyond necessary clinical care, in this study. Echelon Contour is used for transection and resection in colorectal surgical procedures per its instructions for use (IFU).
Baylor Scott and White
St Louis, Missouri, United States
Washington University
Dallas, Texas, United States
Number of Participants with Echelon Contour Success
Echelon Contour success based on surgeon responses on question 1 in the surgeon reported outcome measures (SROM) will be reported. Surgeon will be asked to choose option "Yes" or "No" for following question: Did Echelon Contour provide acceptable performance considering other therapeutic alternatives?
Time frame: interoperative
Number of Participants with Device-related Adverse Events (AEs)
An AE is defined as any untoward medical occurrence, regardless of its relationship to the study device or the study procedure. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs throughout the duration of the clinical study.
Time frame: 28 days post-procedure
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