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

Not Applicable

Completed

• Conditions: Left-sided Colorectal Resection : Diverticular Diseases; Left-sided Colorectal Resection : Rectal Neoplasms; Left-sided Colorectal Resection : Colonic Neoplasms
• Interventions: Device: use of the TRIDENT system

• Registration Number: NCT05973227
• Lead Sponsor: Intuitive Surgical

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.

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 Timeline

• Study Start: 2023-07-06
• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-07-26
• Study First Posted: 2023-08-02
• Primary Completion: 2024-05-21
• Study Completion: 2024-05-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
interventional arm (use of TRIDENT system)	use of the TRIDENT system	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
- 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.

Trial Locations

Locations (1)

CHU Strasbourg; 🇫🇷 Strasbourg, France