NCT06550908

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

5 months

First QC Date

August 8, 2024

Last Update Submit

August 6, 2025

Conditions

Keywords

Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Accuracy for Paris classification

    Ability to correctly classify colonic polyps using the Paris classification

    9 months

Secondary Outcomes (4)

  • Range of misclassifications for Paris classification

    9 months

  • Influence of endoscopy experience on accuracy for correct Paris classification

    9 months

  • Influence of time to complete course on accuracy for correct Paris classification

    9 months

  • Influence regular usage of Paris classification on accuracy for correct Paris classification

    9 months

Study Arms (2)

Training with real images

ACTIVE COMPARATOR

Physicians train using the Paris classification with real colon polyp images

Other: Lutetia Training Plattform - real images

Training with artificial images

EXPERIMENTAL

Physicians train using the Paris classification with artificial colon polyp images

Other: Lutetia Training Plattform - artifical images

Interventions

Training platform Lutetia offers training the Paris classification using real images of colon polyps.

Training with real images

Training platform Lutetia offers training the Paris classification using artificial images of colon polyps.

Training with artificial images

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physicians with or without experience in colonoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Würzburg

Würzburg, Germany

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander Hann

    Wuerzburg University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 13, 2024

Study Start

April 15, 2025

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations