NCT04362657

Brief Summary

This study aimed to investigate the clinical application of Artificial Intelligence Software for computer aided diagnosis (CAD), for real-time anatomical coverage, automatic Identification, classification and interpretation of abnormal lesions in upper GI endoscopy, and benchmarking their accuracy compared to endoscopists.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration 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

April 20, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

2.3 years

First QC Date

April 22, 2020

Last Update Submit

November 4, 2023

Conditions

Upper Gastrointestinal DisorderOGD

Keywords

Computer aided diagnosisOGD

Outcome Measures

Primary Outcomes (1)

  • Anatomical coverage during OGD by CAD

    Rate of complete examination of the Upper GI tract during OGD guided by CAD

    24 hours

Secondary Outcomes (2)

  • Procedure time

    24 hours

  • Endoscopists satisfactory score

    24 hours

Study Arms (1)

Computer aided diagnosis

EXPERIMENTAL

Using CAD to assist in completeness of the examination during OGD

Diagnostic Test: Computer Aided Diagnosis

Interventions

Computer Aided DiagnosisDIAGNOSTIC_TEST

Computer Aided diagnosis is an environment-enhancing technology developed to aid humans to improve their accuracy, speed and confidence by providing live feedback during the procedure, on request, or after the procedure has been completed.

Computer aided diagnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing diagnostic OGD for evaluation of their symptoms
  • Age \>= 18

You may not qualify if:

  • Patients refusing consent/not willing to participate in the study
  • Patients where biopsies cannot or have not been taken
  • Patients with history of gastrectomy
  • Patient admitted for upper gastrointestinal bleeding
  • Patient who are not suitable for EGD examination (such as acute peritonitis with suspected perforated bowel)
  • Pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Combined Endoscopy Center, Prince of Wales Hospital

Hong Kong, 00000, Hong Kong

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Diagnosis, Computer-Assisted

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnosis

Study Officials

  • Philip Chiu, MD

    Chinese 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
Professor

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 27, 2020

Study Start

April 20, 2020

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)