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Evaluation of Neoplasia With Artificial Intelligence in Gastrointestinal Endoscopy

NCT ID: NCT04937647

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-16

Study Completion Date

2026-06-03

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastrointestinal Neoplasms

Keywords

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gastrointestinal neoplasia artificial intelligence

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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collection of endoscopic images and videos

collection of endoscopic images and videos

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Portsmouth Hospitals NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pradeep Bhandari, Prof

Role: PRINCIPAL_INVESTIGATOR

Portsmouth Hospitals University NHS Trust

Locations

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Portsmouth Hospitals NHS University Trust

Portsmouth, Hampshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Laura Marshall

Role: CONTACT

Phone: 02392286000

Email: [email protected]

Facility Contacts

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Laura Marshall

Role: primary

Other Identifiers

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PHT/2020/58

Identifier Type: -

Identifier Source: org_study_id