Evaluation of Neoplasia With Artificial Intelligence in Gastrointestinal Endoscopy

Gastrointestinal Neoplasms Clinical Trial

— NEW-AGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04937647
• Other study ID #: PHT/2020/58
• Status: Recruiting
• Start date: June 16, 2021
• Est. completion date: June 15, 2023

Study information

• Verified date: April 2023
• Source: Portsmouth Hospitals NHS Trust
• Contact: Laura Marshall
• Phone: 02392286000
• Email: Laura.Marshall2[@]porthosp.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1650
• Est. completion date: June 15, 2023
• Est. primary completion date: June 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Neoplasms

Intervention

Other:
• collection of endoscopic images and videos
collection of endoscopic images and videos

Locations

Country	Name	City	State
United Kingdom	Portsmouth Hospitals NHS University Trust	Portsmouth	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Portsmouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neoplasia detection rate	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	Accuracy of AI diagnosis	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
Secondary	Endoscopist neoplasia detection rate	Detection rate of endoscopists at various levels of experience	during the procedure, up to 24 weeks, at 1 year, through study completion