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

Intuitive Surgical

Status: Completed

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

Treatments: Device: use of the TRIDENT system

Study type: Interventional

Funder types: Industry

Identifiers

NCT05973227

1094572-01C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

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)

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

interventional arm (use of TRIDENT system)

Experimental group

Treatment:

Device: use of the TRIDENT system