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

Sponsor

Intuitive Surgical (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05973227

Collaborator

(none)

Enrollment

Location

Arm

11.9

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Left-sided Colorectal Resection : Diverticular Diseases Left-sided Colorectal Resection : Colonic Neoplasms Left-sided Colorectal Resection : Rectal Neoplasms	Device: use of the TRIDENT system	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Actual Study Start Date :

Jul 6, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: interventional arm (use of TRIDENT system)	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.

Arm

Intervention/Treatment

Experimental: interventional arm (use of TRIDENT system)

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.

Outcome Measures

Primary Outcome Measures

image quality (sharpness, brightness, etc) and surgeon's feedback regarding the ergonomics and safety of Trident System v1.0 during surgery. [30 days FU]
descriptive analysis on the quality images by the engineering design team and feedback provided by clinical experts (surgeons) according to ad hoc form evaluating: 1) ergonomics aspects; 2) workflow; 3) risks of breaching sterility; 4) Speed of image acquisition.

Secondary Outcome Measures

- level of oxygenation (StO2) of the exteriorized colon before resection with the Trident System v1.0 - the level of oxygenation (StO2) provided by the system at the site chosen by the surgeon based on the clinical evaluation. [surgery day]
Measurement of StO2 values at the resection site determined by the surgeon based on his clinical judgment and measurement of StO2 levels over the entire length of the colon exteriorized and visible in the field of view of the Trident System v1.0.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient scheduled for a left-sided colorectal resection, irrespective of the surgical approach (open surgery, laparoscopic surgery,) because of:
Colon cancer OR
Sigmoid diverticular disease OR
Rectal cancer
All genders
Age > 18 years old
Ability to understand the information related to the study protocol