NCT05133544

Brief Summary

Colonoscopy is considered the gold standard for diagnosis of colonic polyps. However, it was reported that colonoscopy could still miss colonic polyps. Many attempts have been made to improve the detection rate of colonoscopy. Artificial intelligence (AI) is a promising new technique to improve detection rate of colonic adenoma. However, it remains uncertain whether whether the combined use of Endocuff and AI assisted examination could help to further improve the adenoma detection rate. This is a prospective randomized trial comparing the use of endocuff with AI, AI alone or conventional colonoscopy examination on adenoma detection rate.

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
656

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

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

First Submitted

Initial submission to the registry

November 12, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

April 6, 2023

Status Verified

April 1, 2023

Enrollment Period

1.6 years

First QC Date

November 12, 2021

Last Update Submit

April 4, 2023

Conditions

Colonic AdenomaColonic PolypColonic Cancer

Keywords

Artificial intelligenceColonoscopyEndocuffDetectionComputer-aided

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate

    The proportion of patients with at least one adenomas

    One month after colonoscopy

Secondary Outcomes (7)

  • Polyp detection rate

    One month after colonoscopy

  • Sessile serrated adenomas detection rate

    One month after colonoscopy

  • Sessile serrated polyps detection rate

    One month after colonoscopy

  • Advanced adenoma detection rates

    One month after colonoscopy

  • Mean number of polyp per patient

    One month after colonoscopy

  • +2 more secondary outcomes

Study Arms (3)

Endocuff- AI assisted colonoscopy

ACTIVE COMPARATOR

Endocuff (Olympus, Hong Kong) and AI assisted colonoscopy will be used

Device: Endocuff with AI

AI-assisted colonoscopy

ACTIVE COMPARATOR

AI assisted colonoscopy will be used

Device: AI alone

Conventional colonoscopy

NO INTERVENTION

Conventional colonoscopy will be used without AI or Endocuff.

Interventions

Endocuff with AIDEVICE

Use of endocuff with computer assisted polyp detection

Endocuff- AI assisted colonoscopy
AI aloneDEVICE

Use of computer assisted polyp detection

AI-assisted colonoscopy

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the Queen Mary Hospital, Tung Wah Hospital and Tuen Mun Hospital in Hong Kong will be recruited.

You may not qualify if:

  • Patients will be excluded if they have history of inflammatory bowel disease, colorectal cancer, previous bowel resection, Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes, bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe. Moreover, after randomization, if the cecum could not be intubated for various reasons or Boston Bowel Preparation Scale (BBPS) score is \<2, these patients will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • Lui TK, Lam CP, To EW, Ko MK, Tsui VWM, Liu KS, Hui CK, Cheung MK, Mak LL, Hui RW, Wong SY, Seto WK, Leung WK. Endocuff With or Without Artificial Intelligence-Assisted Colonoscopy in Detection of Colorectal Adenoma: A Randomized Colonoscopy Trial. Am J Gastroenterol. 2024 Jul 1;119(7):1318-1325. doi: 10.14309/ajg.0000000000002684. Epub 2024 Feb 2.

    PMID: 38305278DERIVED

MeSH Terms

Conditions

Colonic PolypsColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Wai Keung Leung, MD

    The University of Hong Kong

    STUDY DIRECTOR

Central Study Contacts

Ka Luen, Thomas Lui, MBBS

CONTACT

22554048klluitc@yahoo.com.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
Clinical Associate Professor

Study Record Dates

First Submitted

November 12, 2021

First Posted

November 24, 2021

Study Start

May 1, 2022

Primary Completion

December 1, 2023

Study Completion

February 1, 2024

Last Updated

April 6, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)