Evaluation of Neoplasia With Artificial Intelligence in Gastrointestinal Endoscopy (NEW-AGE)

Portsmouth Hospitals NHS Trust

Status: Enrolling

Conditions: Gastrointestinal Neoplasms

Treatments: Other: collection of endoscopic images and videos

Study type: Observational

Funder types: Other

Identifiers

NCT04937647

PHT/2020/58

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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