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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Left-sided Colorectal Resection : Diverticular Diseases; Left-sided Colorectal Resection : Colonic Neoplasms; Left-sided Colorectal Resection : Rectal Neoplasms
• Intervention / Treatment: Device: use of the TRIDENT system

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marie Allouis; Phone Number: +33 786 480 495; Email: EU Clinical Affairs <DL-Department-ClinicalAffairs-EMEA@intusurg.com>

Study Locations

• France
  • Strasbourg, France
    • Recruiting
    • CHU Strasbourg
    • Contact: Didier Mutter, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

• Pregnancy or breastfeeding
• Contraindications to anaesthesia
• Inability to provide a written informed consent
• Inclusion in a different ongoing clinical trial
• Emergency procedure
• Abdomino-perineal resection
• Hartmann procedure
• Patient is part of vulnerable population (e.g., prisoners, mentally disabled)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
image quality (sharpness, brightness, etc) and surgeon's feedback regarding the ergonomics and safety of Trident System v1.0 during surgery.	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.	30 days FU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- 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.	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.	surgery day

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Principal Investigator: Didier Mutter, MD, PhD, CHU Strasbourg

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Colorectal surgery; Tissue oxygenation; TRIDENT system
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Diverticulum; Diverticular Diseases
• Other Study ID Numbers: 1094572-01C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No