Evaluation of Neoplasia With Artificial Intelligence in Gastrointestinal Endoscopy (NEW-AGE)

December 16, 2025 updated by: Portsmouth Hospitals NHS Trust

Collection of Endoscopic Images and Videos for Validation of Artificial Intelligence Algorithms for Computer Aided Detection and Characterisation of Early Gastrointestinal Neoplasia

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an investigator initiated; multi-centre study and will be conducted in two phases. Validation & Optimization phase, where routinely collected and anonymized endoscopic images and videos from the departmental teaching and training library will be used to validate, and if needed fine-tune and improve, the accuracy of an AI algorithm. Testing phase, where the evaluation of AI algorithms performance will be conducted on a prospective basis. The ground truth (standard) will be expert assessment and histological diagnosis.

This study has no direct impact on patient's clinical care, and collection of all endoscopic data will take place during standard endoscopy procedures done for purely clinical indications. No additional procedures, biopsies or interventions will be performed as a part of this study.

Study Type

Observational

Enrollment (Estimated)

1650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability 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.

Description

Inclusion Criteria:

-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.

Exclusion Criteria

The participant may not enter the study if ANY of the following apply:

  • Patients with endoscopically active severe oesophagitis
  • Poor bowel preparation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neoplasia detection rate
Time Frame: during the procedure, up to 24 weeks, at 1 year, through study completion
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of AI diagnosis
Time Frame: during the procedure, up to 24 weeks, at 1 year, through study completion
Accuracy of real time optical diagnosis (characterization) of GI neoplasia by the AI algorithm.
during the procedure, up to 24 weeks, at 1 year, through study completion
Endoscopist neoplasia detection rate
Time Frame: during the procedure, up to 24 weeks, at 1 year, through study completion
Detection rate of endoscopists at various levels of experience
during the procedure, up to 24 weeks, at 1 year, through study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portsmouth Hospitals NHS Trust

Investigators

  • Principal Investigator: Pradeep Bhandari, Prof, Portsmouth Hospitals University NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2021

Primary Completion (Estimated)

June 3, 2026

Study Completion (Estimated)

June 3, 2026

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 23, 2021

First Posted (Actual)

June 24, 2021

Study Record Updates

Last Update Posted (Estimated)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 16, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHT/2020/58

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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