Comparative Analysis of AI Software for Enhanced Polyp Detection and Diagnosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI.
- Who it may be relevant to
- Registry conditions: Colonic Polyp, Colon Lesion. Basic parameters: 50 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Analysis of AI Software and Conventional Colonoscopy for Enhanced Polyp Detection and Diagnosis: A Randomized Controlled Trial
Overview
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.
Interventions
- Device AI
AI system
Primary outcome measures
- To compare the effectiveness of AI systems in characterizing polyps with conventional histology [Time frame: During procedure (5minutes)]
- Comparison of Adenoma Detection Rates (ADR) between colonoscopies assisted by Artificial Intelligence (AI) and conventional colonoscopies without AI [Time frame: During procedure (up to 40 minutes)]
- To assess and compare the costs associated with AI-assisted colonoscopy versus conventional colonoscopy. [Time frame: During procedure (5minutes)]
Eligibility criteria
Inclusion criteria
- Age > 50 years
- Elective colonoscopy
Exclusion criteria
- Patient declines to participate in the study.
- Age < 50 years
- Unprepared bowel
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Sweden · 1 center
- Sahlgrenska University Hospital — Gothenburg
Identifiers
NCT: NCT06077435 · 981840