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NCT Number: NCT06251700

Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong

Location status: Recruiting

Location contact

Louis Lau

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

ENDO-AID CADe

Device

ENDO-AID CADe will be used during the withdrawal process of the colonscopy

Primary outcomes

  1. Post-colonoscopy adenomas at year 3

    Time frame: During the colonoscopy

    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.

Secondary outcomes

  1. Post-colonoscopy AA

    Time frame: During the colonoscopy

    Incidence of post-colonoscopy advanced adenomas

  2. Post-colonoscopy advanced neoplasms

    Time frame: During the colonoscopy

    Incidence of post-colonoscopy advanced neoplasms

  3. Post-colonoscopy SSL

    Time frame: During the colonoscopy

    Incidence of post-colonoscopy SSL

  4. Post-colonoscopy CRC

    Time frame: During the colonoscopy

    Incidence of post-colonoscopy CRC

  5. Post-colonoscopy adenomas and advanced adenomas

    Time frame: During the colonoscopy

    Number of post-colonoscopy adenomas and advanced adenomas

  6. Size and location of post-colonoscopy adenomas and advanced adenomas

    Time frame: During the colonoscopy

    Size and location of post-colonoscopy adenomas and advanced adenomas

  7. High-risk and low-risk group according to USMSTF guideline

    Time frame: During the colonoscopy

    Proportion of subjects re-classified as high-risk and low-risk groups according to USMSTF guideline

Study contacts

Contact information is provided by the study sponsor or research team.

Felix Sia

CONTACT

[email protected]

26370428

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: ENDOAID-PRO

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 9, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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