da Vinci SP® Investigational Device Exemption Study in Colorectal Procedures
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- STATUS
- Recruiting
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- End date
- Dec 6, 2027
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- participants needed
- 60
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- sponsor
- Intuitive Surgical
Summary
To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior resections or right colectomy.
Description
Primary Performance:
- The primary performance endpoint will be assessed as the ability to complete the planned da Vinci SP-assisted colorectal procedure without conversion to an alternate approach. Conversion to an alternate approach comprises conversion to open, multiport laparoscopic*, multiport robotic or hand-assisted approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned procedure using the alternate approach.
- Performing an extracorporeal anastomosis is not considered a conversion ** Use of additional assistant laparoscopic port(s) is not considered a conversion Laparoscopic or robotic with hand assistance
Primary Safety:
The primary safety endpoint will be assessed as the incidence of all intraoperative and post-operative adverse events that occur through the 42-day follow-up period
Details
| Condition | Colon cancer; rectal cancer, Benign or Malignant Rectal or Colon Tumors, Colon Cancer Screening, Colorectal Cancer, Rectal Cancer, rectal carcinoma |
|---|---|
| Treatment | Robotic Assisted Surgery |
| Clinical Study Identifier | NCT04403022 |
| Sponsor | Intuitive Surgical |
| Last Modified on | 4 October 2022 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
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