Artificial Intelligence (AI) Validation Study for Polyp Detection

Status Completed

Clinical Trial Summary

Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy

Clinical Trial Description

This is an investigator-initiated multicentre non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided diagnostic (CAD) tool in polyp detection implemented as second observer during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Patients referred for a screening surveillance or therapeutic colonoscopy will undergo a colonoscopy performed by an endoscopist with moderate to high adenoma detection rate (ADR > 20% and < 50%) while a second observer will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows (1) true positive, (2) false negative, (3) other positive and (4) obvious false positive. When a doubtful detection is made by the AI-system, the second observer will ask to re-evaluate the indicated region. When the detection is clear, the endoscopist and second observer do not communicate. The entire procedure is recorded. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04378660
Study type	Interventional
Source	Universitaire Ziekenhuizen Leuven
Contact
Status	Completed
Phase	N/A
Start date	October 30, 2019
Completion date	April 18, 2020

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05178095` - Artificial Intelligence in Colonic Polyp Detection	N/A
Completed	`NCT03179358` - Clinical Trial Verifying C-REX LapAid and C-REX DMH/DMHC	N/A
Completed	`NCT04551001` - Evaluation of Cold Forcep and Cold Snare Polypectomy for Polyps Less Than or Equal to 3mm in Size During Colonoscopy	N/A
Completed	`NCT04551014` - Evaluation of EverLift in the Performance of Polypectomy for Polyps 4-9mm	N/A
Completed	`NCT04442607` - Clinical vAliDation of ARTificial Intelligence in POlyp Detection	N/A
Completed	`NCT05499546` - Virtual Scale Function SCALE EYE: Variability and Systematic Differences	N/A
Completed	`NCT04195646` - Computer Aided Detection of Polyps During Colonoscopy Procedures	N/A
Completed	`NCT04899700` - Linked Color Imaging Versus White Light Endoscopy for the Evaluation of Scars of Non-pedunculated Polyps. LCI Scar Study.	N/A
Recruiting	`NCT04500392` - High-flow Nasal Cannula Oxygenation Decrease Hypoxia in Sedated Gastrointestinal Endoscopes in Obesity	N/A
Recruiting	`NCT06447012` - Artificial Intelligence Development for Colorectal Polyp Diagnosis
Completed	`NCT04357158` - Breath Analysis as an Additional Test for Colorectal Cancer Screening to Reduce the Number of Unnecessary Colonoscopies	N/A
Completed	`NCT05389397` - De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas	N/A
Completed	`NCT04032912` - The Non-Optical Resect and Discard Study (NORD)
Recruiting	`NCT05730192` - EAGLE Trial CADDIE Artificial Intelligence Endoscopy	N/A
Completed	`NCT05829447` - Combining Artificial Intelligence With Balloon Mucosal Exposure Device for Polyp Detection in Screening Individuals	N/A
Completed	`NCT04647266` - Pronostic Score of Morbidity to Determine Risk of Complications After Endoscopic Submucosal Dissection for Colorectal Lesions
Not yet recruiting	`NCT06271941` - Prophylactic Double Thermal Ablation After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps	N/A
Recruiting	`NCT04117100` - Advanced Endo-therapeutic Procedure : Registry-based Observational Study
Active, not recruiting	`NCT03089268` - Molecular and Histological Characteristics of Serrated Lesions of the Colon
Completed	`NCT04924543` - OPtical Diagnosis Training to Improve Dysplasia Characterisation in IBD	N/A