Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy

Study Overview
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Brief Summary
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The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.

Official Title
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Accuracy of Endo-aid in Consecutive Patients Referred for Colonoscopy - ACCENDO-Colo Study

Conditions
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Adenoma Colon, Colonic Adenoma

Intervention / Treatment
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* Device: ENDO-Aid by Olympus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years or ≤85 Patients undergoing screening, follow-up, or diagnostic colonoscopy Exclusion Criteria: Suspected or known inflammatory bowel disease Colonic resection Taking anticoagulants or antiaggregants that contraindicate the performance of therapy Patients with incomplete colonoscopy Patients with inadequate preparation using the Boston Colonic Preparation Scale (BBPS). A cleaning quality of less than 2 points in any of the 3 colonic sections will be considered inadequate. Inability to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CADe Colonoscopy<br>Colonoscopy with the help of CADe system (ENDO-Aid) | Device: ENDO-Aid by Olympus<br>* Colonoscopy assisted by ENDO-AID device<br>|
| No Intervention: Conventional Colonoscopy<br>Standard Colonoscopy with white light | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate (ADR) | ADR defined as the proportion of patients with at least 1 adenoma detected. | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection rate (PDR) | PDR defined as the proportion of patients with at least 1 polyp detected. | 1 years | 
| Polyp per colonoscopy (PPC) | PPC defined as total number of polyps resected divided by the total number of colonoscopies. | 1 years | 
| Adenoma per colonoscopy (APC) | APC defined as total number of histologically confirmed adenomas resected divided by the total number of colonoscopies. | 1 years | 
| Sessile serrated lesion detection rate (SSLDR) | SSLDR percentage of patients who have 1 or more histologically confirmed sessile serrated lesion resected divided by the total number of colonoscopies. | 1 years | 
| Advanced adenoma detection rate (AADR) | AADR Adenomas are classified as advanced with a size >= 10mm and/or a (tubulo)villous histology and/or high-grade dysplasia (HGD) | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADR, CADe, Endo-AID