NCT04937647

Brief Summary

This study aims to validate and evaluate AI algorithms for detection and characterization of early GI neoplasia.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,650

participants targeted

Target at P75+ for all trials

Timeline
0mo left

Started Jun 2021

Longer than P75 for all trials

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 Progress99%
Jun 2021Jun 2026

First Submitted

Initial submission to the registry

June 9, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

June 16, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2026

Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

5 years

First QC Date

June 9, 2021

Last Update Submit

December 16, 2025

Conditions

Keywords

gastrointestinal neoplasiaartificial intelligence

Outcome Measures

Primary Outcomes (1)

  • neoplasia detection rate

    neoplasia detection rate of the AI algorithms in different locations of the GI tract.

    during the procedure, up to 24 weeks, at 1 year, through study completion

Secondary Outcomes (2)

  • Accuracy of AI diagnosis

    during the procedure, up to 24 weeks, at 1 year, through study completion

  • Endoscopist neoplasia detection rate

    during the procedure, up to 24 weeks, at 1 year, through study completion

Interventions

collection of endoscopic images and videos

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In phase (1), all previously collected, anonymized and stored endoscopic images and videos of early GI neoplasia in the departmental endoscopy teaching and training library. In phase (2), all eligible patients coming for upper and/or lower GI endoscopy for clinical reasons in participating centres will be approached for enrolment into this study.

You may qualify if:

  • The participant must meet ALL of the following criteria to be considered eligible for the study:
  • Male or Female, aged 18 years or above.
  • Requiring gastroscopy and/or colonoscopy to investigate gastrointestinal symptoms, or as part of screening or ongoing surveillance of GI neoplasia.
  • Participant is willing and able to give informed consent for participation in the study.

You may not qualify if:

  • The participant may not enter the study if ANY of the following apply:
  • Patients with endoscopically active severe oesophagitis
  • Poor bowel preparation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portsmouth Hospitals NHS University Trust

Portsmouth, Hampshire, PO63LY, United Kingdom

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Pradeep Bhandari, Prof

    Portsmouth Hospitals University NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 24, 2021

Study Start

June 16, 2021

Primary Completion (Estimated)

June 3, 2026

Study Completion (Estimated)

June 3, 2026

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations