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Evaluation of Neoplasia With Artificial Intelligence in Gastrointestinal Endoscopy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04937647
Acronym
NEW-AGE
Enrollment
70
Registered
2021-06-24
Start date
2021-06-16
Completion date
2025-01-27
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Neoplasms

Keywords

gastrointestinal neoplasia, artificial intelligence

Brief summary

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

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.

Interventions

OTHERcollection of endoscopic images and videos

collection of endoscopic images and videos

Sponsors

Portsmouth Hospitals NHS Trust
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
neoplasia detection rateduring the procedure, up to 24 weeks, at 1 year, through study completionneoplasia detection rate of the AI algorithms in different locations of the GI tract.

Secondary

MeasureTime frameDescription
Accuracy of AI diagnosisduring the procedure, up to 24 weeks, at 1 year, through study completionAccuracy of real time optical diagnosis (characterization) of GI neoplasia by the AI algorithm.
Endoscopist neoplasia detection rateduring the procedure, up to 24 weeks, at 1 year, through study completionDetection rate of endoscopists at various levels of experience

Countries

United Kingdom

Contacts

PRINCIPAL_INVESTIGATORPradeep Bhandari, Prof

Portsmouth Hospitals NHS Trust

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026