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RecruitingNCT06251700

Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence

Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence - a Prospective Longitudinal Follow-up of Randomized Controlled Trial

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
775 (estimated)
Sponsor
Chinese University of Hong Kong · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

We hypothesize that AI-assisted colonoscopy can reduce post-colonoscopy neoplasia incidence after 3 years, over standard colonoscopy. Moreover, this protective effect may allow surveillance intervals to be lengthened, by modifying long-term outcome of high-risk subgroup.

Detailed description

Between April 2021 and July 2022, our group completed a parallel-group, randomized controlled trial in Hong Kong. \[ENDOAID-TRAIN study; NCT04838951\] 856 subjects undergoing colonoscopies were randomized 1:1 to receive colonoscopies with CADe (ENDO-AID, Olympus Co., Japan) or standard colonoscopies (control). Our study proved that AI-assisted colonoscopies could increase the overall ADR, especially small-to-medium size adenomas. It remains questionable whether the increased detection and removal of these non-advanced adenomas can be translated into any sustained long-term benefit. The impact of this AI-driven intensive surveillance on general population and healthcare system is also largely unknown. In this research project, we aim to assess the long-term effectiveness of AI-assisted colonoscopy on adenoma recurrence and PCCRC prevention, by conducting a real-world, prospective study with longitudinal extension from a randomized trial.

Conditions

Interventions

TypeNameDescription
DEVICEENDO-AID CADeENDO-AID CADe will be used during the withdrawal process of the colonscopy

Timeline

Start date
2024-01-24
Primary completion
2026-12-31
Completion
2027-04-30
First posted
2024-02-09
Last updated
2024-10-29

Locations

1 site across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT06251700. Inclusion in this directory is not an endorsement.