Comparative Analysis of AI Software for Enhanced Polyp Detection and Diagnosis
NCT ID: NCT06077435
Last Updated: 2025-11-24
Study Results
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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RECRUITING
NA
915 participants
INTERVENTIONAL
2023-03-01
2026-06-01
Brief Summary
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The purpose of this study is to evaluate whether artificial intelligence (AI) improves the detection of polyps and whether the system can classify the type and severity of detected changes. The investigators will also assess if there are any differences between the various AI systems and whether the polyps that may be missed are benign or malignant.
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Detailed Description
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The study is a randomized controlled clinical trial conducted at Västra Götaland region. Patients are randomized to receive either AI or conventional endoscopy, and each endoscopy unit has access to at least one AI device. Informed consent is obtained from patients before the examination.
Before the examination, patients are asked if they want to participate in the study. If the patient wishes to participate, informed consent is obtained. The endoscopist then draws a slip from an envelope, determining whether conventional colonoscopy or AI will be used. During conventional colonoscopy, the patient is examined according to routine practice. After the examination, a questionnaire is filled out, recording various findings from the examination. During AI examinations, the AI system is activated only during instrument withdrawal. The system identifies polyps and alerts the endoscopist. Additionally, two of the AI systems (GI-Genius, CADEYE) have the ability to characterize the detected polyps and provide an interpretation of whether the changes are benign or malignant. After the examination, a similar questionnaire is completed as in conventional colonoscopy.
Method: Data Collection
Basic data will be recorded, including the reason for the examination, other illnesses, medications, demographic data such as gender, age, family history of cancer, and the time of the examination (morning or afternoon). During the examination, the following will be recorded: the number of polyps, macroscopic classification of polyps, AI system's characterization of the polyps, bowel cleansing quality, laxative method, medication during the examination, complications occurring during or after the examination. Withdrawal time is recorded, as well as the number of false-positive polyps and supplementation with histological data of polyps after review by the pathologist. All materials and costs associated with the examination are recorded.
Three different AI systems will be used at the various hospital sites, namely EndoAid (Olympus), CADEYE (Fujinon), and GI-Genius (Medtronic). All units will randomize each examination to either AI or non-AI.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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CAD-EYE
AI system 1. Sealed envelopes in blocks of four were used for randomisation.
AI
AI system
GI-GENIUS
AI system 2. Sealed envelopes in blocks of four were used for randomisation
AI
AI system
Endo-AID
AI system 3. Sealed envelopes in blocks of four were used for randomisation
AI
AI system
No AI
No AI. conventional examination. Sealed envelopes in blocks of four were used for randomisation
No interventions assigned to this group
Interventions
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AI
AI system
Eligibility Criteria
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Inclusion Criteria
* Elective colonoscopy
Exclusion Criteria
* Age \< 50 years
* Unprepared bowel
50 Years
90 Years
ALL
No
Sponsors
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Sahlgrenska University Hospital
OTHER
Responsible Party
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Jonas Varkey
Principal investigator, Senior Consultant, MD, PhD,
Principal Investigators
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Per Hedenstrom, MD. Ph D
Role: STUDY_DIRECTOR
Sahlgrenska University Hospital
Locations
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Sahlgrenska University Hospital
Gothenburg, Gothenbburg, Sweden
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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981840
Identifier Type: -
Identifier Source: org_study_id
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