An interventional study of AI in Colonic Polyp and Colon Lesion, sponsored by Sahlgrenska University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Diagnostic
Purpose \& Research Questions
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.
Materials: Selection, Representativeness, and Grouping
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.
377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.
This study's planned enrollment of 915 is above the median of 274 across 250 interventional studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
AI system 1. Sealed envelopes in blocks of four were used for randomisation.
Device: AI
AI system 2. Sealed envelopes in blocks of four were used for randomisation
Device: AI
AI system 3. Sealed envelopes in blocks of four were used for randomisation
Device: AI
No AI. conventional examination. Sealed envelopes in blocks of four were used for randomisation
AI system
To compare the effectiveness of AI systems in characterizing polyps with conventional histology
The endoscopist's ability to characterize lesions with and without AI will be assessed, and this assessment will be compared to histology
Time frame: During procedure (5minutes)
Comparison of Adenoma Detection Rates (ADR) between colonoscopies assisted by Artificial Intelligence (AI) and conventional colonoscopies without AI
The ADR is typically expressed as a percentage and is calculated using the following formula:Number of colonoscopies with adenoma detection/ Total number of colonoscopies ×100.
Time frame: During procedure (up to 40 minutes)
To assess and compare the costs associated with AI-assisted colonoscopy versus conventional colonoscopy.
Each cost associated with each examination, whether using AI-assisted or conventional colonoscopy, will be recorded prospectively.
Time frame: During procedure (5minutes)
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2023 (actual). Primary completion is estimated for Mar 2026, 36 months after the start.
Of 132 non-industry interventional studies with no phase under Colonic Polyps, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's planned 36 months is above that.
Counting every sponsor, half of 149 studies reached it within 17 months; a quarter within 9 and three quarters within 35.
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