Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06063720
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2023-09-20
Brief Title:
Effective Withdrawal Time and Adenoma Detection Rate
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
A Prospective Evaluation of the Correlation Between Artificial Intelligence-derived Effective Withdrawal Time and Adenoma Detection Rate
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 baseline adenoma detection rate ADR The association between the AI derived EWT with ADR during the prospective colonoscopy series would also be determined The colonoscopy video of participants will be monitored by the AI and the result of EWT will be blinded to the endoscopists
Detailed Description:
This is a prospective colonoscopy trial using artificial intelligence AI real time effective mucosal examination monitor system EndoScreener QC Wision AI 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orifice and ileocecal valve or by intubation of the ileum After cecal intubation is performed the colonoscopy is slowly withdrawn All detected polyps will be removed during the withdrawal only The size measured with biopsy forceps location and morphology of each polyp will be recorded by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 carcinomaThe primary outcome of this study is to correlate the adenoma detection rates of the endoscopists with EWT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None