Comparative Analysis of AI Software for Enhanced Polyp Detection and Diagnosis

Sahlgrenska University Hospital

Status: Enrolling

Conditions: Colon Lesion; Colonic Polyp

Treatments: Device: AI

Study type: Interventional

Funder types: Other

Identifiers

NCT06077435

981840

Details and patient eligibility

About

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.

Full 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.

Enrollment: 915 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 50 years
• Elective colonoscopy

Exclusion criteria

• Patient declines to participate in the study.
• Age < 50 years
• Unprepared bowel

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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915 participants in 4 patient groups

CAD-EYE

Active Comparator group

Description:

AI system 1. Sealed envelopes in blocks of four were used for randomisation.

Treatment:

Device: AI

GI-GENIUS

Active Comparator group

Description:

AI system 2. Sealed envelopes in blocks of four were used for randomisation

Treatment:

Device: AI

Endo-AID

Active Comparator group

Description:

AI system 3. Sealed envelopes in blocks of four were used for randomisation

Treatment:

Device: AI

No AI

No Intervention group

Description:

No AI. conventional examination. Sealed envelopes in blocks of four were used for randomisation