Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05863208
Status:
RECRUITING
Last Update Posted:
2023-05-17
First Post:
2023-05-09
Brief Title:
Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision
Sponsor:
E-DA Hospital
Organization:
E-DA Hospital
Study Overview
Official Title:
Comparison of The Adenoma Detection Rate Between Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision and Standard Colonscopy A Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2023-05
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:
Adenoma detection rate ADR is considered the single most important quality measure in colonoscopy and a higher ADR can reduce the risk of interval colorectal cancer CRC Several kinds of new endoscopes and accessories have been accessed to investigate the abilities of improving the ADR Artificial intelligence AI and Endocuff vision are promising new devices to improve the ADR However the effect of combining AI and Endocuff vision on ADR remains unclear The aim of this prospective randomized study is to compare the ADR of AI plus Endocuff vision AI alone and standard colonoscopy examination
Detailed Description:
This is a prospective single-blinded randomized controlled trial of three different types of colonoscopy examinations by 111 ratio We use EndoAim AI ASUS Taiwan and Endocuff vision Olympus UK assisted colonoscopy in the first group We use AI assisted colonoscopy in the 2nd group We use standard colonoscopy in the 3rd group
Eligible patients are older than 40 years old and receive colonoscopy for either symptomatic or screeningsurveillance All endoscopists should receive training on EndoAim AI systems and Endocuff vision During the procedure experienced endoscopists use high-definition endoscopes EVIS-EXERA 290 video system Olympus Optical Aizu Japan under white light and insert to the cecum in the three different groups The cecal intubation is confirmed by the identification of ileocecal valve and appendiceal orifice
The Boston Bowel Preparation Scale is used for grading the bowel preparation quality The size compared with biopsy forceps location and morphology of polyps are recorded by the independent endoscopist All polyps ae removed by either biopsy or polypectomy The insertion and withdrawal time are measured The time of the polypectomy site is not included in the withdrawal time
Eligible patients are older than 40 years old and receive colonoscopy for either symptomatic or screeningsurveillance All endoscopists should receive training on EndoAim AI systems and Endocuff vision During the procedure experienced endoscopists use high-definition endoscopes EVIS-EXERA 290 video system Olympus Optical Aizu Japan under white light and insert to the cecum in the three different groups The cecal intubation is confirmed by the identification of ileocecal valve and appendiceal orifice
The Boston Bowel Preparation Scale is used for grading the bowel preparation quality The size compared with biopsy forceps location and morphology of polyps are recorded by the independent endoscopist All polyps ae removed by either biopsy or polypectomy The insertion and withdrawal time are measured The time of the polypectomy site is not included in the withdrawal time
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