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

NCT ID: NCT05973227

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-06
• Study Completion Date: 2024-05-21

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

interventional arm (use of TRIDENT system)

Group Type: EXPERIMENTAL

use of the TRIDENT system

Intervention Type: DEVICE

usage of Trident System v1.0, just before the final resection, to obtain some images of the tissue oxygenation.

Interventions

use of the TRIDENT system

usage of Trident System v1.0, just before the final resection, to obtain some images of the tissue oxygenation.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intuitive Surgical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Didier Mutter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Strasbourg

Locations

CHU Strasbourg

Strasbourg, , France

Countries

France

Other Identifiers

1094572-01C

Identifier Type: -

Identifier Source: org_study_id