A Prospective Single-Center Evaluation of SureForm Staplers in Robotic-assisted Colorectal Procedures
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- STATUS
- Recruiting
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- participants needed
- 60
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- sponsor
- Intuitive Surgical
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.
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.
Details
| Condition | Benign Colon Tumor, Malignant Colorectal Tumor, Benign Colorectal Neoplasm |
|---|---|
| Age | 18years - 100years |
| Treatment | Colorectal resection |
| Clinical Study Identifier | NCT04247958 |
| Sponsor | Intuitive Surgical |
| Last Modified on | 19 February 2024 |
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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