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A Prospective Single-Center Evaluation of SureForm Staplers in Robotic-assisted Colorectal Procedures

A Prospective Single-Center Evaluation of SureForm Staplers in Robotic-assisted Colorectal Procedures

Recruiting
18 years and older
All
Phase N/A

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 details
    Benign Colon Tumor
    Malignant Colorectal Tumor
    Benign Colorectal Neoplasm

NCT04247958

Intuitive Surgical

19 February 2024

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