Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy (NAIAD)

The goal of this trial is to determine whether use of a Computer Assisted Detection (CADe) programme leads to an increase in ADR for either units or individual colonoscopists, independent of setting or expertise

Study Overview

• Status: Recruiting
• Conditions: Colonic Polyp; Colo-rectal Cancer; Colonic Adenoma
• Intervention / Treatment: Device: GI Genius (GIG)

Detailed Description

This is a case-control study comparing adenoma detection rate (ADR) in hospitals (and individual colonoscopists), before, during and after use with an artificial intelligence unit called GI Genius™ (GIG). GIG is a Computer-assisted detection (CADe) module that assists the human colonoscopist in real-time, by detecting and marking out polyps during colonoscopy. It has been shown to be effective in expert colonoscopists, but the effect in non-expert, general, colonoscopists is not known.

The investigator wish to deploy GIG into colonoscopy through the UK using a step-wedge design. Sites will be randomly allocated a start date for GIG deployment, collecting data for four months prior to this. In this way, all sites will have the active intervention and will provide their own case-control data. (4 months collection prior to activating GIG, 4 months with GIG, 4 months afterwards without GIG)

The study will concentrate on non-expert colonoscopists, to determine whether GIG can increase ADR. Patients will undergo the same colonoscopy that they would have had in any case, with no additional trial visits or interventions. There will be no alteration to the usual care pathway from the patient's perspective.

If the investigator can prove GIG increases ADR in this way, it will provide support to roll out this technology routinely to improve the quality of colonoscopy nationwide.

• Study Type: Observational
• Enrollment (Estimated): 4000

Contacts and Locations

• Study Contact: Name: Prof Bu'Hussain B Hayee, PHD FRCP; Phone Number: 02032996044; Email: b.hayee@nhs.net
• Study Contact Backup: Name: Dr Olaolu Olabintan, MBBS MRCP; Phone Number: 07939056819; Email: olaolu.olabintan@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • King's College Hospital NHS Foundation Trust
    • Contact: Alena B Marynina; Phone Number: +442032996044; Email: alena.marynina@nhs.net
    • Contact: Olaolu Olabintan; Phone Number: 07939 056819; Email: olaolu.olabintan@nhs.net
    • Principal Investigator: Bu'Hussain B Hayee, MBBS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Unselected patients scheduled for diagnostic colonoscopy

Description

Inclusion Criteria:

• Any patient aged 18-85 scheduled for colonoscopy by current NHSE / British Society of Gastroenterology criteria

Exclusion Criteria:

• Colonoscopy being performed for polyp surveillance
• Unable to provide informed, written consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All patients; Patient ≥18 years old, with capacity to consent, scheduled for diagnostic colonoscopy	Device: GI Genius (GIG); GIG is an artificial intelligence unit that assists human colonoscopist in real-time to detect polyps during colonoscopy. Four months collection period prior to activating GIG, then four months with GIG, and Four months afterwards without GIG; Other Names: CADe

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CADe-ADR in real world practice	The primary outcome measure will be adenoma detection rate. This will be studied across three phases: prior to use of CADe (baseline practice), while using CADe (study period) and finally after CADe (without the device in situ: "washout" phase).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
APC	Mean adenomas per colonoscopy (APC)	24 months
Polyp characteristics	Polyp size (mm) and location (in colonic segments)	24 months
Procedure time	Total procedure (insertion+withdrawal) and withdrawal time	24 months

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Collaborators: Medtronic; National Institute for Health Research, United Kingdom
• Investigators: Principal Investigator: Prof Bu'Hussain B Hayee, King's College Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 11, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Colorectal cancer; Artificial Intelligence; Computer assisted detection (CADe); Adenoma Detection Rate (ADR)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Pathological Conditions, Anatomical; Polyps; Intestinal Polyps; Adenoma; Colonic Polyps
• Other Study ID Numbers: 292323

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No