AUGUR-AI - Indocyanine Green Fluorescence Angiography Representer

Launched by MATER MISERICORDIAE UNIVERSITY HOSPITAL · Nov 26, 2024

Keywords

ClinConnect Summary

The AUGUR-AI trial is studying a new computer system that helps surgeons during colorectal surgery, which is a procedure used to treat bowel diseases like cancer. During surgery, doctors often use special cameras that can see both normal light and infrared light to make sure tissues are getting enough blood flow. This trial aims to see if the computer can accurately interpret the images from these cameras in real-time, just like an experienced surgeon would. The goal is to make surgeries safer and reduce complications, such as leaks where the tissue is joined back together after removing diseased parts.

To participate in this study, you need to be at least 18 years old and have a colorectal condition that requires surgery. You should also be in good health overall, with acceptable lab test results. If you decide to join, you will receive the standard care during your surgery, and while the computer will analyze video images from your surgery, its findings won't be shown to the surgeon during the procedure to ensure that their decisions are not influenced. Keep in mind that if you are pregnant, have certain health conditions, or have allergies to specific contrast agents, you may not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant is willing and able to give informed consent for participation in the study.
• • Aged 18 years or above.
• • Colorectal disease requiring segmental resection with anastomosis.
• • Participant has clinically acceptable laboratory results, including liver function tests.
• • In the Investigator's opinion, is able and willing to comply with all study requirements.
• • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
• Exclusion Criteria:
• The participant may not enter the study if ANY of the following apply:
• • Participant who is pregnant, lactating or planning pregnancy during the course of the study.
• • Significant renal or hepatic impairment.
• • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
• • Allergy to intravenous contrast agent or indocyanine green.
• • Concurrent use of anticonvulsants, bisulphite containing drugs, methadone and nitrofurantoin.