Colonic PolypLUTETIA2NCT06550908
Training Physicians to Differentiate the Paris Classification Using Artificial Colon Polyp Images
A study testing Lutetia Training Plattform - real images and Lutetia Training Plattform - artifical images in people with Colonic Polyp and Colon Adenoma, run by Wuerzburg University Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp, Colon Adenoma
- What is being tested?
- Lutetia Training Plattform - real images and Lutetia Training Plattform - artifical images
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2025to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physicians with or without experience in colonoscopy
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University hospital Würzburg
Würzburg
Prof. Dr. med. Hann, +49 931 201 45918, hann_a@ukw.de
About this study
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.
- Conditions
- Colonic Polyp, Colon Adenoma
- Being tested
- Lutetia Training Plattform - real images, Lutetia Training Plattform - artifical images
- Keywords
- Colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutetia Training Plattform - real imagesOther
Training platform Lutetia offers training the Paris classification using real images of colon polyps.
Lutetia Training Plattform - artifical imagesOther
Training platform Lutetia offers training the Paris classification using artificial images of colon polyps.
| Study group | Role | What they receive |
|---|---|---|
| Training with real images | Active comparator | Physicians train using the Paris classification with real colon polyp images Receives: Other: Lutetia Training Plattform - real images |
| Training with artificial images | Experimental | Physicians train using the Paris classification with artificial colon polyp images Receives: Other: Lutetia Training Plattform - artifical images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy for Paris classification
Ability to correctly classify colonic polyps using the Paris classification
Measured: 9 months
Secondary outcomes (4)
Range of misclassifications for Paris classification
Number of misclassification categorizes (eg 1-4)
Measured: 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
Measured: 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
Measured: 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
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start15 Apr 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander Hann, Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550908
- Sponsor's protocol ID
- 2022120701-2
- Acronym
- LUTETIA2
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Physicians to Differentiate the Paris Classification Using Artificial Colon Polyp Images
- ClinicalTrials.gov ID
- NCT06550908
- Acronym / sponsor ID
- LUTETIA2 / 2022120701-2
- Conditions
- Colonic Polyp, Colon Adenoma
- Keywords
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training with real images | Active comparator | Other: Lutetia Training Plattform - real imagesPhysicians train using the Paris classification with real colon polyp images |
| Training with artificial images | Experimental | Other: Lutetia Training Plattform - artifical imagesPhysicians train using the Paris classification with artificial colon polyp images |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physicians with or without experience in colonoscopy
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lutetia Training Plattform - real imagesTraining platform Lutetia offers training the Paris classification using real images of colon polyps. | Other | Training with real images |
| Lutetia Training Plattform - artifical imagesTraining platform Lutetia offers training the Paris classification using artificial images of colon polyps. | Other | Training with artificial images |
Primary outcome
Accuracy for Paris classification
Time frame: 9 months
Ability to correctly classify colonic polyps using the Paris classification
4 secondary outcomes
Range of misclassifications for Paris classification
Time frame: 9 months
Influence of endoscopy experience on accuracy for correct Paris classification
Time frame: 9 months
Influence of time to complete course on accuracy for correct Paris classification
Time frame: 9 months
Influence regular usage of Paris classification on accuracy for correct Paris classification
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Hann principal investigator
Wuerzburg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lutetia Training Plattform - real images and Lutetia Training Plattform - artifical images in people with Colonic Polyp and Colon Adenoma, run by Wuerzburg University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Hann, MD (0049931201 ext. 45918, hann_a@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy for Paris classification (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.