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OpenTrials
Completed

NCT Number: NCT05973227

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Strasbourg

Strasbourg, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

use of the TRIDENT system

Device

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

Primary outcomes

  1. image quality (sharpness, brightness, etc) and surgeon's feedback regarding the ergonomics and safety of Trident System v1.0 during surgery.

    Time frame: 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 outcomes

  1. - 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study title

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

Acronym: TRIDENT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2023
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.