NCT04422548

Brief Summary

To date, there is a lack of large-scale randomized controlled study using AI assistance in the detection of polyps/adenoma in a screening population. The correlation of fecal occult blood test (FIT or FOBT) and the advantage of AI-assisted colonoscopy has not been investigated. There is also a lack of information of the benefit of AI-assisted colonoscopy in experienced colonoscopist versus trainee/resident.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,994

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2020

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

June 5, 2020

Last Update Submit

July 14, 2020

Conditions

Screening Colonoscopy

Outcome Measures

Primary Outcomes (2)

  • Per-patient ADR in each group

    For the AI-Assisted group, it is defined as the number of patients with at least 1 adenoma identified in the colon divided by the total number of patients in the AI-Assisted group.

    12 months

  • Per-patient ADR in each group

    For the Standard group, it is defined as the number of patients with at least 1 adenoma identified in the colon divided by the total number of patients in the Standard group.

    12 months

Study Arms (2)

AI-assisted Group

ACTIVE COMPARATOR
Procedure: AI-assisted Colonoscopy

Standard

ACTIVE COMPARATOR
Procedure: Standard Colonoscopy

Interventions

AI-assisted ColonoscopyPROCEDURE

This is a multi-center prospective randomized controlled study comparing real-time AI-assisted colonoscopy versus standard colonoscopy in a real-life setting.

AI-assisted Group
Standard ColonoscopyPROCEDURE

Standard Colonoscopy

Standard

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving colonoscopy screening
  • Patients aged 45-75 years
  • Both patients who have or have not done a FIT test and both FIT +ve and FIT -ve subjects

You may not qualify if:

  • Patients who have symptom(s) suggestive of colorectal diseases
  • Patients who have a history of inflammatory bowel disease, colorectal cancer or polyposis syndrome (anaemia, bloody stool, tenesmus and obstructive symptoms)
  • Patients who had colonoscopy or other investigation of colon and rectum in the past 10 years
  • Patients who had surgery for colorectal diseases
  • Patients who cannot tolerate bowel preparation or have suboptimal bowel preparations (Boston Bowel Preparation Scale)
  • Cannot reach caecum
  • Patients who are incompetent in giving informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • Xu H, Tang RSY, Lam TYT, Zhao G, Lau JYW, Liu Y, Wu Q, Rong L, Xu W, Li X, Wong SH, Cai S, Wang J, Liu G, Ma T, Liang X, Mak JWY, Xu H, Yuan P, Cao T, Li F, Ye Z, Shutian Z, Sung JJY. Artificial Intelligence-Assisted Colonoscopy for Colorectal Cancer Screening: A Multicenter Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Feb;21(2):337-346.e3. doi: 10.1016/j.cgh.2022.07.006. Epub 2022 Jul 19.

    PMID: 35863686DERIVED

Central Study Contacts

Andrew Ming Yeung HO

CONTACT

26371398andrewho@cuhk.edu.hk

Thomas Yuen Tung LAM

CONTACT

26370355thomaslam@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 9, 2020

Study Start

November 28, 2019

Primary Completion

November 27, 2020

Study Completion

November 27, 2020

Last Updated

July 16, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)