Training Physicians to Differentiate the Paris Classification Using Artificial Colon Polyp Images (LUTETIA2)

Training in endoscopy is essential for the early detection of precursors of colorectal cancer. Up to now, this training has been carried out with image collections of findings and in practice when working on patients. The investigators want to use artificial intelligence (AI) to better train doctors to recognise these precursors. By using generative AI, the investigators were able to create realistic images that comply with data protection regulations and whose content can be predefined. Parts of the image can also be regenerated so that it is possible to create different precancerous stages in the same place in the image.

In this study the investigators want to train physicians using real images or artificial images in order to compare which version helps classify polyps better.

Study Overview

• Status: Recruiting
• Conditions: Colonic Polyp; Colon Adenoma
• Intervention / Treatment: Other: Lutetia Training Plattform - real images; Other: Lutetia Training Plattform - artifical images

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Hann, MD; Phone Number: 45918 0049931201; Email: hann_a@ukw.de
• Study Contact Backup: Name: Ronja Weber; Phone Number: 40242 0049931201; Email: ronja.weber@stud-mail.uni-wuerzburg.de

Study Locations

• Germany
  • Würzburg, Germany
    • Recruiting
    • University Hospital Wurzburg
    • Contact: Prof. Dr. med. Hann; Phone Number: +49 931 201 45918; Email: hann_a@ukw.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Physicians with or without experience in colonoscopy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Training with real images; Physicians train using the Paris classification with real colon polyp images	Other: Lutetia Training Plattform - real images; Training platform Lutetia offers training the Paris classification using real images of colon polyps.
Experimental: Training with artificial images; Physicians train using the Paris classification with artificial colon polyp images	Other: Lutetia Training Plattform - artifical images; Training platform Lutetia offers training the Paris classification using artificial images of colon polyps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy for Paris classification	Ability to correctly classify colonic polyps using the Paris classification	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of misclassifications for Paris classification	Number of misclassification categorizes (eg 1-4)	9 months
Influence of endoscopy experience on accuracy for correct Paris classification	Influence of endoscopy experience measured in number of perfomed colonoscopies on accuracy for correct Paris classification	9 months
Influence of time to complete course on accuracy for correct Paris classification	Influence of time to complete course measured in days on accuracy for correct Paris classification	9 months
Influence regular usage of Paris classification on accuracy for correct Paris classification	Influence regular usage of Paris classification (yes/no) on accuracy for correct Paris classification	9 months

Collaborators and Investigators

• Sponsor: Wuerzburg University Hospital
• Investigators: Principal Investigator: Alexander Hann, Wuerzburg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Colonoscopy
• Additional Relevant MeSH Terms: Neoplasms; Pathological Conditions, Anatomical; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Intestinal Polyps; Adenoma; Polyps; Colonic Polyps
• Other Study ID Numbers: 2022120701-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No