EndoStyle: Artificial Intelligence Image Transformation Tool for Colonoscopy

NCT ID: NCT06553326

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-15

Study Completion Date

2025-08-22

Brief Summary

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The study addresses the limitations of current AI systems in gastrointestinal endoscopy, which are tipically trained with data from a single type of endoscopy processor and have limited expert-annotated images. The investigators aim to develop and validate EndoStyle, an AI system that can generate images in the style of various processors from a single reference image. EndoStyle will be tested by showing endoscopists colonoscopy sequences with different image types to determine if they can distinguish AI-transformed images. Success would enhance AI training for diverse clinical setups.

Detailed Description

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The use of artificial intelligence (AI) in gastrointestinal endoscopy has become widespread. However, these systems are often only trained with data from a single type of endoscopy processor, which limits their applicability. In addition, the availability of images annotated by experts is limited, which affects data variability and thus the performance of AI systems.

The aim of this study is to develop a new artificial intelligence (AI) based system (EndoStyle) and validate its authenticity by means of a survey among physicians, which is able to generate multiple images in the style of different processor types (including Olympus, Pentax and Storz) from a single endoscopy reference image.

The investigators hypothesis is that the AI system is able to successfully change the image style of video processors, with the differences being imperceptible to the endoscopist's eye.

The methodology consists of showing to multiple endoscopists 28 colonoscopy sequences of 10 seconds duration each. In each one of them 3 images will be shown that can be all the possible combinations of images belonging to positive control, negative control, and Endostyle (intervention group). By performing a statistical comparison of the percentages of selected images for each group the investigators will be able to establish whether the participants are able to distinguish the images transformed by the AI.

If the results corroborate our hypothesis, our system could generate images that would allow a more customized training of AI systems for each clinical setup.

Conditions

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Colon Cancer Colon Rectal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Positive control

The image shown to the participant belongs to the same colonoscopy shown in the 10 second video-sequence.

No interventions assigned to this group

Negative control

The image shown to the participant belongs to the same colonoscopy shown in the 10 second video-sequence.

No interventions assigned to this group

EndoStyle (intervention group)

The image shown to the participant does not belong to the 10 second colonoscopy video-sequence but has been transformed with AI to simulate the style of the video.

EndoStyle

Intervention Type DEVICE

The EndoStyle system is able to transform the style of the different video-processor images.

Interventions

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EndoStyle

The EndoStyle system is able to transform the style of the different video-processor images.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Physicians with experience in colonoscopy.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wuerzburg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexander Hann, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Würzburg

Locations

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University Clinic of Würzburg

Würzburg, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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AI05

Identifier Type: -

Identifier Source: org_study_id

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