Evaluation of Neoplasia with Artificial Intelligence in Gastrointestinal Endoscopy

Recruiting

• Conditions: Gastrointestinal Neoplasms

• Registration Number: NCT04937647
• Lead Sponsor: Portsmouth Hospitals NHS Trust

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.

Study Timeline

• Study First Submitted: 2021-06-09
• Study Start: 2021-06-16
• Study First Submitted QC: 2021-06-23
• Study First Posted: 2021-06-24
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07
• Primary Completion: 2026-06-03
• Study Completion: 2026-06-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1650

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
neoplasia detection rate	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 Outcome Measures

Name	Time	Method
Endoscopist neoplasia detection rate	during the procedure, up to 24 weeks, at 1 year, through study completion	Detection rate of endoscopists at various levels of experience
Accuracy of AI diagnosis	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.

Trial Locations

Locations (1)

Portsmouth Hospitals NHS University Trust; 🇬🇧 Portsmouth, Hampshire, United Kingdom