Prince of Wales Hospital
Shatin, Hong Kong Island, Hong Kong
NCT Number: NCT05414448
The investigators hypothesize that the combined use of CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) would improve the adenoma detection rate when compared to CADe system alone.
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Notify Me45 year–85 year
All sexes
Interventional
Not applicable
Shatin, Hong Kong Island, Hong Kong
High polyp miss rates were reported in standard colonoscopies. As a result, a significant proportion of interval CRC was attributed to the missed lesions during index colonoscopy. Risk factors of missed lesions included proximal location, serrate or flat morphology, poor bowel preparation, short withdrawal time and endoscopist experience.
To overcome this pitfall, various methods were developed to improve adenoma detection rate (ADR), including distal attachment devices. Among the mucosal exposure devices, Endocuff Vision® was shown to be superior than conventional colonoscopies.
Recently, artificial intelligence and automatic computer-aided polyp detection (CADe) systems have developed rapidly and revolutionized the medical field. Nevertheless, there was a potential limitation of 'blind spot' if the endoscopist failed to expose the colonic mucosa adequately leading to missed lesions. To date, no available data or ongoing clinical trial was reported regarding the combined use of CADe and mucosal exposure devices. It may enhance the performance of CADe and provide a novel definitive solution to this unaddressed yet important clinical problem.
In this prospective parallel randomized controlled trial, we aim to evaluate the impact of combined use of a new CADe system (ENDOAID) and mucosal exposure device (Endocuff Vision®) on colorectal neoplasia detection.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ENDOCUFF mucousal exposure device will be used during withdrawal process of the colonoscopy.
Time frame: During the colonoscopy
adenoma detection rate
Time frame: During the colonoscopy
<5mm, 5-10mm, >10mm
Time frame: During the colonoscopy
caecum, ascending colon, hepatic flexure, transverse colon, splenic flexure, descending colon, sigmoid colon, rectum
Time frame: During the colonoscopy
Mean number of adenomas per colonoscopy
Time frame: During the colonoscopy
Advanced adenoma detection rate
Time frame: During the colonoscopy
Sessile serrated lesion (SSL) detection rate
Time frame: During the colonoscopy
Polyp detection rate
Time frame: During the colonoscopy
defined as absence of adenoma or SSL or cancer within resected specimen
Time frame: During the colonoscopy
Caecal intubation time
Time frame: During the colonoscopy
excluding interventions
Time frame: During the colonoscopy
Total procedural time
Time frame: During the colonoscopy
defined as computer artifacts due to colonic mucosal wall or bowel content lasting for >2 seconds
Chinese University of Hong Kong
Other
Combination of Artificial Intelligence (ENDOAID) and Mucosal Exposure Device (ENDOCUFF) to Enhance Colorectal Neoplasia Detection: a Randomized Controlled Trial
Acronym: AIDEN
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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.
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