AUGUR-AI - Indocyanine Green Fluorescence Angiography Representer
NCT06708819 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2024-11-27
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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