AUGUR-AI - Indocyanine Green Fluorescence Angiography Representer

NCT06708819 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-11-27

No results posted yet for this study

Summary

Surgery can effectively treat colorectal cancer, but it is a complex procedure with risks and complications. Surgeons often rely on cameras to visually guide their instruments during operations, especially in minimally invasive ("keyhole") and endoscopic procedures. The camera is connected to a computer and generates the internal scene onto a display screen, which the surgeon looks at throughout the procedure, helping them make informed decisions throughout the operation. Fluorescence-guided surgery uses a particular type of camera that can detect images in both normal light and in the near-infrared range. To work, it needs the administration of an agent called indocyanine green to a patient and then the camera can see if the agent is in the tissue of interest to the operation at the time of the surgery. In this way, decisions regarding blood supply ("perfusion") can be helped, especially related to safety in joining together portions of tissue after removal of disease. The equipment and agent are approved for use in this way and have very good safety profiles. Many international studies have already demonstrated that the use of fluorescence-guided surgery is associated with lower rates of leaks when disease bowel segments are removed, and the healthy ends are joined back together.

Previous work we have done has shown that sophisticated computing methods can learn to interpret the fluorescence patterns to a similar standard as a surgeon who is very experienced in fluorescence-guided surgery.

In this study, we aim to assess whether the computer system we have developed work in real-time, in theatre to provide a reliable interpretation of the fluorescence pattern, that would match how an expert would interpret the same pattern. The system's analysis will not impact on the operation; instead, video images will be recorded, processed and analysed by our computer system. The results of the interpretation will not be shown to the operating surgeon during the procedure to avoid any impact on decision-making.

Conditions

  • Colorectal Surgery
  • Colorectal Resection
  • Anastomosis, Surgical
  • Fluorescence Guided Surgery
  • Indocyanine Green
  • Perfusion Imaging
  • Anastomotic Leaks

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    collaborator OTHER
  • Humanitas Research Hospital IRCCS, Rozzano-Milan

    collaborator OTHER
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER
  • University Hospital, Geneva

    collaborator OTHER
  • The Leeds Teaching Hospitals NHS Trust

    collaborator OTHER
  • Oxford University Hospitals NHS Trust

    collaborator OTHER
  • Frimley Park Hospital NHS Trust

    collaborator OTHER
  • IRCCS San Raffaele

    collaborator OTHER
  • UZ Leuven

    collaborator UNKNOWN
  • University College Dublin

    collaborator OTHER
  • Mater Misericordiae University Hospital

    lead OTHER

Principal Investigators

  • Ronan Cahill · Mater Misericordiae University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06708819 on ClinicalTrials.gov