NCT04227795

Brief Summary

A prospective validation of real time deep learning artificial intelligence model for detection of missed colonic polyps

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2020

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

1 month

First QC Date

January 10, 2020

Last Update Submit

March 2, 2020

Conditions

Keywords

Artificial intelligenceColonoscopyDeep learningDetectionComputer-aided

Outcome Measures

Primary Outcomes (1)

  • Adenoma miss rate

    The number of patient had at least one missed adenoma

    During the colonoscopy procedure

Secondary Outcomes (3)

  • Total number of adenoma missed

    During the colonoscopy procedure

  • Colonic polyp miss rate

    During the colonoscopy procedure

  • Total number of missed polyps

    During the colonoscopy procedure

Study Arms (1)

Artificial intelligence-Assisted real time colonoscopy

EXPERIMENTAL

AI assisted real-time detection of colonic lesions

Device: Artificial intelligence-Assisted real time colonoscopy

Interventions

The colonoscopy was performed under artificial intelligence assistance

Artificial intelligence-Assisted real time colonoscopy

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • consecutive adult patients, age 40 or above, who were scheduled to have outpatient colonoscopy in the Queen Mary Hospital were invited to participate

You may not qualify if:

  • Patients were excluded if they were unable to provide informed consent, considered to be unsafe for taking biopsy or polypectomy including patients with bleeding tendency and those with severe comorbid illnesses.
  • Also, patients with history of inflammatory bowel disease, familial adenomatous polyposis, Peutz-Jeghers syndrome or other polyposis syndromes were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Lui TKL, Hui CKY, Tsui VWM, Cheung KS, Ko MKL, Foo DCC, Mak LY, Yeung CK, Lui TH, Wong SY, Leung WK. New insights on missed colonic lesions during colonoscopy through artificial intelligence-assisted real-time detection (with video). Gastrointest Endosc. 2021 Jan;93(1):193-200.e1. doi: 10.1016/j.gie.2020.04.066. Epub 2020 May 4.

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

  • Ka Luen, Thomas Lui

    Queen Mary Hospital, the University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 10, 2020

First Posted

January 14, 2020

Study Start

January 1, 2020

Primary Completion

February 1, 2020

Study Completion

March 1, 2020

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations