NCT05973227

InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections

InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections: Observational First-in-human Pilot Safety Trial -TRIDENT-

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to assess the safety and technical feasibility of a new imaging system, used during colorectal resection surgery, named Trident in version 1.0, which could be used by the surgeon during colorectal procedures to obtain information on intestinal tissue oxygenation.

Detailed description

This is a prospective, non-randomized, single center, feasibility trial. All consecutive patients that fulfil the inclusion/exclusion criteria will be informed about the possibility to be included in the present clinical investigation. Only subjects that have signed the study informed consent will be included in the study. The Trident System v1.0 will be used only during approximately 2 to 5 minutes during a precise surgical step, i.e., just before the final resection of the surgical specimen. Patients will be prospectively followed at 30 days post-surgery. Data will be collected prospectively from the medical records.

Conditions

• Left-sided Colorectal Resection : Diverticular Diseases
• Left-sided Colorectal Resection : Colonic Neoplasms
• Left-sided Colorectal Resection : Rectal Neoplasms

Interventions

Type	Name	Description
DEVICE	use of the TRIDENT system	usage of Trident System v1.0, just before the final resection, to obtain some images of the tissue oxygenation.

Timeline

• Start date: 2023-07-06
• Primary completion: 2024-05-21
• Completion: 2024-05-21
• First posted: 2023-08-02
• Last updated: 2024-07-22

Locations

1 site across 1 country: France