NCT06077435

Comparative Analysis of AI Software for Enhanced Polyp Detection and Diagnosis

Comparative Analysis of AI Software and Conventional Colonoscopy for Enhanced Polyp Detection and Diagnosis: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 915 (estimated)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colonic Polyp
• Colon Lesion

Interventions

Type	Name	Description
DEVICE	AI	AI system

Timeline

• Start date: 2023-03-01
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2023-10-11
• Last updated: 2025-11-24

Locations

1 site across 1 country: Sweden