Queen Mary Hospital, the University of Hong Kong
Hong Kong
NCT Number: NCT06345105
The goal of this observational study is to assess the correlation between the artificial intelligence (AI) derived effective withdrawal time (EWT) during colonoscopy and endoscopists' adenoma per colonoscopy (APC), polyp per colonoscopy(PPC), adenoma detection rate (ADR), polyp detection rate (PDR) and during colonoscopy for each endoscopists. The association between the AI derived EWT with all colonoscopy outcomes during the prospective colonoscopy series would also be determined. The colonoscopy video of participants will be monitored by the AI. The result will be compared with standard withdrawal time (SWT).
Looking for future studies?
Notify Me40 year and older
All sexes
Observational
Hong Kong
This is a prospective colonoscopy trial using artificial intelligence (AI) real time effective mucosal examination monitor system (EndoScreener QC, Wision A.I. Shanghai & Chengdu). Low residue diet will be taken by all patients two days before the scheduled colonoscopy. Oral polyethylene glycol lavage solution is used for bowel preparation as in usual hospital practice. All examination will be performed with high-definition endoscopes (EVIS-EXERA 290 video system, Olympus Optical, Tokyo, Japan) under white light by experienced endoscopists. In all colonoscopy examination, colonoscope will be first advanced to the cecum as confirmed by identification of the appendiceal orifice and ileocecal valve or by intubation of the ileum. After cecal intubation is performed, the colonoscopy is slowly withdrawn. All detected polyps will be removed during the withdrawal only. The size (measured with biopsy forceps), location and morphology of each polyp will be recorded by an independent observer. The withdrawal time (minus the polypectomy site) will be measured by a stopwatch and with a minimum of 6 minutes. The bowel preparation quality will be graded according to the Boston Bowel Preparation Scale. The AI derived (AI) real time effective mucosal examination monitor system (EndoScreen QC) will be initiated during scope withdrawal, starting from cecum to anus. The polypectomy or biopsy time will be removed as determination of standard withdrawal time. All endoscopists will be blinded to the results of AI real time monitoring of EWT. All polyp specimens removed will be clearly labelled and send for histological examination. All resected and biopsy specimens are fixed in 10% buffered formalin solution, and examined histologically by hematoxylin and eosin staining. The histopathological diagnosis is determined by experienced pathologists, who are blinded to the assigned endoscopic system, according to the World Health Organization (WHO) criteria. Advanced adenomas are defined as adenoma ≥10 mm in diameter or with villous histology in 25% or high-grade dysplasia (HGD), or carcinoma.The primary outcome of this study is to correlate the adenoma detection rates of the endoscopists with EWT.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Artificial intelligence monitoring of effective withdrawal time
Time frame: During the colonoscopy
Adenoma per colonoscopy of the endoscopists
Time frame: During that colonoscopy
Adenoma detection rate of the endoscopists
Time frame: During that colonoscopy
Polyp detection rate of the endoscopists
Time frame: During colonoscopy
Polyp per colonoscopy of the endoscopists
Time frame: During the colonoscopy
Serrated Lesion per Colonoscopy of the endoscopist
Time frame: During colonoscopy
Serrated Lesion Detection Rate of the endoscopist
The University of Hong Kong
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06173258
Colon Adenoma, Colon Polyp
Iglesias, Italy
View Trial DetailsNCT05275556
Colon Adenoma, Colon Lesion
Rochester, Minnesota, United States
View Trial DetailsNCT06073405
Artificial Intelligence, Colon Polyp
Ariccia, Rome, Italy
View Trial DetailsNCT03462706
Colon Adenoma, Colon Cancer
Indianapolis, Indiana, United States
View Trial Details