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Clinical Trial Summary

The primary objective of this study is to evaluate the performance of SureForm™ Staplers (60 and 45) for transection and/or creation of anastomosis during robotic-assisted colorectal procedures.


Clinical Trial Description

This is a prospective, single-center observational study to evaluate the performance of SureForm™ Staplers during robotic-assisted resections of either ascending or transverse or descending or sigmoid colon or rectum. Subjects with either a suspected or confirmed benign or malignant disease of the colon and rectum who are scheduled to undergo a robotic-assisted resection of the colon or rectum will be asked to provide informed consent for their participation in the study. The study will be conducted at one institution with two surgeons performing the colorectal procedures. The surgeons will be using either the da Vinci Xi or X Surgical System which ever they use as per their standard of care for the colorectal procedure. Stapling will be performed with SureForm™ Staplers and any of the reloads as per the surgeon's standard of care for the transection and/or creation of anastomosis during robotic-assisted colorectal procedures. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04247958
Study type Observational
Source Intuitive Surgical
Contact
Status Completed
Phase
Start date January 30, 2020
Completion date December 31, 2023

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