NCT06495645

Brief Summary

This prospective randomized trial compares AI-assisted upper gastrointestinal endoscopy with high definition upper gastrointestinal endoscopy in term of missed rate of gastric neoplasm. The investigators hypothesize the miss rate of high definition upper gastrointestinal endoscopy is higher than AI-assisted upper gastrointestinal endoscopy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
8mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress70%
Nov 2024Dec 2026

First Submitted

Initial submission to the registry

June 25, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 11, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1.8 years

First QC Date

June 25, 2024

Last Update Submit

November 19, 2025

Conditions

Gastric NeoplasmArtificial Intelligence

Keywords

Gastric NeoplasmArtificial intelligenceMiss rate

Outcome Measures

Primary Outcomes (1)

  • Gastric neoplasia miss rate

    the number of newly detected gastric neoplasia in the second examination divided by the total number of gastric neoplasia detected in both examinations for each patient.

    during the intervention

Secondary Outcomes (9)

  • Gastric neoplasia detection rate

    during the intervention

  • The biopsy rate

    during the intervention

  • The number of gastric neoplasms per patient

    during the intervention

  • The miss rate of patients with gastric neoplasms

    during the intervention

  • The positive predictive value (PPV) for gastric neoplasms

    during the intervention

  • +4 more secondary outcomes

Study Arms (2)

AI-HD group

EXPERIMENTAL

AI-assisted upper gastrointestinal endoscopy follow immediately by high definition (HD) upper gastrointestinal endoscopy

Device: AI-assisted upper gastrointestinal endoscopy

HD-AI group

ACTIVE COMPARATOR

HD upper gastrointestinal endoscopy follow immediately by AI-assisted upper gastrointestinal endoscopy

Device: AI-assisted upper gastrointestinal endoscopy

Interventions

AI-assisted upper gastrointestinal endoscopyDEVICE

AI-assisted upper gastrointestinal endoscopy

AI-HD groupHD-AI group

Eligibility Criteria

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

You may qualify if:

  • Patients aged 40 or older
  • Scheduled for elective upper endoscopy

You may not qualify if:

  • Pregnant women,
  • Inability to provide written informed consent
  • Prior gastrectomy, and
  • Patients deemed unsuitable or high-risk for endoscopy with severe comorbid illnesses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Mary Hospital, the University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Thomas Ka-Luen Lui

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Ka-Luen Lui

CONTACT

+852 97360997tkllui@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

June 25, 2024

First Posted

July 11, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)