Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy

Recruiting

• Conditions: Colonic Adenoma; Colonic Polyp; Colo-rectal Cancer
• Interventions: Device: GI Genius (GIG)

• Registration Number: NCT05870332
• Lead Sponsor: King's College Hospital NHS Trust

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-23
• Study Start: 2023-10-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06
• Primary Completion: 2025-01-01
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All patients	GI Genius (GIG)	Patient ≥18 years old, with capacity to consent, scheduled for diagnostic colonoscopy

Primary Outcome Measures

Name	Time	Method
CADe-ADR in real world practice	24 months	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom