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

• Sponsor: Portsmouth Hospitals NHS Trust (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04937647
• Collaborator: (none)
• Enrollment: 1,650
• Location: 1
• Anticipated Duration (Months): 18
• Patients Per Site Per Month: 91.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Neoplasms	Other: collection of endoscopic images and videos

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 Design

• Study Type: Observational
• Anticipated Enrollment: 1650 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Collection of Endoscopic Images and Videos for Validation of Artificial Intelligence Algorithms for Computer Aided Detection and Characterisation of Early Gastrointestinal Neoplasia
• Actual Study Start Date: Jun 16, 2021
• Anticipated Primary Completion Date: Dec 16, 2022
• Anticipated Study Completion Date: Dec 16, 2022

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Portsmouth Hospitals NHS University Trust	Portsmouth	Hampshire	United Kingdom	PO63LY

Sponsors and Collaborators

• Portsmouth Hospitals NHS Trust

Investigators

• Principal Investigator: Pradeep Bhandari, Prof, Portsmouth Hospitals University NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Portsmouth Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT04937647
• Other Study ID Numbers: PHT/2020/58
• First Posted: Jun 24, 2021
• Last Update Posted: Mar 29, 2022
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Portsmouth Hospitals NHS Trust: gastrointestinal neoplasia; artificial intelligence
• Additional relevant MeSH terms: Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms

Study Results

No Results Posted as of Mar 29, 2022