NCT06553326

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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
6 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2025

Completed
Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 8, 2024

Last Update Submit

August 25, 2025

Conditions

Keywords

colonoscopyArtificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Perceptual Indistinguishability of AI-Transformed Endoscopic Images

    Comparison of the accuracy for each study group.

    5 months

Secondary Outcomes (3)

  • Time Taken for Image Identification

    5 months

  • Influence of regularly used processor

    5 months

  • Influence of endoscopy experience

    5 months

Study Arms (3)

Positive control

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

Negative control

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

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.

Device: EndoStyle

Interventions

EndoStyleDEVICE

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

EndoStyle (intervention group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants to the survey will be physicians with experience in colonoscopy.

You may qualify if:

  • Physicians with experience in colonoscopy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic of Würzburg

Würzburg, Bavaria, 97080, Germany

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Alexander Hann, MD

    University Hospital of Würzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 14, 2024

Study Start

August 15, 2024

Primary Completion

August 22, 2025

Study Completion

August 22, 2025

Last Updated

September 2, 2025

Record last verified: 2025-08

Locations