- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06553326
EndoStyle: Artificial Intelligence Image Transformation Tool for Colonoscopy (EndoStyle)
EndoStyle: Survey of Physicians on Endoscopic Image Style Transfer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bavaria
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Würzburg, Bavaria, Germany, 97080
- University Clinic of Würzburg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Physicians with experience in colonoscopy.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Positive control
The image shown to the participant belongs to the same colonoscopy shown in the 10 second video-sequence.
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|
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Negative control
The image shown to the participant belongs to the same colonoscopy shown in the 10 second video-sequence.
|
|
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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.
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The EndoStyle system is able to transform the style of the different video-processor images.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceptual Indistinguishability of AI-Transformed Endoscopic Images
Time Frame: 5 months
|
Comparison of the accuracy for each study group.
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5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time Taken for Image Identification
Time Frame: 5 months
|
Time taken to assess the different tasks according to each study group.
|
5 months
|
|
Influence of regularly used processor
Time Frame: 5 months
|
Influence of regularly used endscopy processor during clinical work for the perceptual indistinguishability of AI-transformed endoscopic images with defined processor classes
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5 months
|
|
Influence of endoscopy experience
Time Frame: 5 months
|
Influence of experience in endoscopy measured in lifetime performed colonscopies on perceptual indistinguishability of AI-transformed endoscopic images
|
5 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexander Hann, MD, University Hospital of Würzburg
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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