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Recruiting

NCT Number: NCT04937647

Evaluation of Neoplasia With Artificial Intelligence in Gastrointestinal Endoscopy

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Portsmouth Hospitals NHS University Trust

Portsmouth, Hampshire, PO63LY, United Kingdom

Location status: Recruiting

Location contact

Laura Marshall

CONTACT

[email protected]

02392286000 ext. 5211

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

collection of endoscopic images and videos

Other

collection of endoscopic images and videos

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Marshall

CONTACT

[email protected]

02392286000 ext. 5210

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Registry information

Official study title

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

Acronym: NEW-AGE

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2021
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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