Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence
ENDOAID-PRO
1 other identifier
interventional
775
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 24, 2024
CompletedFirst Submitted
Initial submission to the registry
February 1, 2024
CompletedFirst Posted
Study publicly available on registry
February 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
October 29, 2024
October 1, 2024
2.9 years
February 1, 2024
October 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Post-colonoscopy adenomas at year 3
The primary endpoint is the incidence of post-colonoscopy adenomas at year 3, which is the composite of new occurrence and metachronous recurrence of adenomas during surveillance.
During the colonoscopy
Secondary Outcomes (7)
Post-colonoscopy AA
During the colonoscopy
Post-colonoscopy advanced neoplasms
During the colonoscopy
Post-colonoscopy SSL
During the colonoscopy
Post-colonoscopy CRC
During the colonoscopy
Post-colonoscopy adenomas and advanced adenomas
During the colonoscopy
- +2 more secondary outcomes
Study Arms (1)
Intervention arm
EXPERIMENTALCADe system will be used during withdrawal phase of colonscopy
Interventions
ENDO-AID CADe will be used during the withdrawal process of the colonscopy
Eligibility Criteria
You may qualify if:
- Subjects are eligible if:
- (i) They underwent randomization to receive colonoscopy with/without CADe in ENDOAID-TRAIN study \[NCT04838951\]; (ii) They are fit and willing to undergo surveillance colonoscopy at year 3; (iii) Written informed consent obtained.
You may not qualify if:
- Subjects will be excluded from the study if they have any of the followings:
- (i) Incomplete colonoscopy during index procedure; (ii) Known residual colorectal neoplasia not removed (except hyperplastic polyps); (iii) Underwent unscheduled interval colonoscopy before year 3; (iv) Contraindications to surveillance colonoscopy at year 3; (v) Advanced comorbid (American Society of Anesthesiologists grade 4 or above); (vi) History of CRC, hereditary polyposis syndrome or inflammatory bowel disease; (vii) History of colectomy at any time point.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Prince of Wales Hospital
Hong Kong, Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 1, 2024
First Posted
February 9, 2024
Study Start
January 24, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
April 30, 2027
Last Updated
October 29, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share