NCT05870332

Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 4,000 (estimated)
• Sponsor: King's College Hospital NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colonic Polyp
• Colonic Adenoma
• Colo-rectal Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-10-16
• Primary completion: 2025-01-01
• Completion: 2025-05-31
• First posted: 2023-05-23
• Last updated: 2024-03-06

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study