Comparative Analysis of AI Software for Enhanced Polyp Detection and Diagnosis
1 other identifier
interventional
915
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2023
CompletedFirst Submitted
Initial submission to the registry
September 27, 2023
CompletedFirst Posted
Study publicly available on registry
October 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedNovember 24, 2025
November 1, 2025
3 years
September 27, 2023
November 19, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
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.
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.
During procedure (5minutes)
Study Arms (4)
CAD-EYE
ACTIVE COMPARATORAI system 1. Sealed envelopes in blocks of four were used for randomisation.
GI-GENIUS
ACTIVE COMPARATORAI system 2. Sealed envelopes in blocks of four were used for randomisation
Endo-AID
ACTIVE COMPARATORAI system 3. Sealed envelopes in blocks of four were used for randomisation
No AI
NO INTERVENTIONNo AI. conventional examination. Sealed envelopes in blocks of four were used for randomisation
Interventions
Eligibility Criteria
You may qualify if:
- Age \> 50 years
- Elective colonoscopy
You may not qualify if:
- Patient declines to participate in the study.
- Age \< 50 years
- Unprepared bowel
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sahlgrenska University Hospital
Gothenburg, Gothenbburg, 41345, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Per Hedenstrom, MD. Ph D
Sahlgrenska University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator, Senior Consultant, MD, PhD,
Study Record Dates
First Submitted
September 27, 2023
First Posted
October 11, 2023
Study Start
March 1, 2023
Primary Completion
March 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
November 24, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share