Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy

Colo-rectal Cancer Clinical Trial

— NAIAD  

Official title:

Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05870332
• Other study ID #: 292323
• Status: Recruiting
• Start date: October 16, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: March 2024
• Source: King's College Hospital NHS Trust
• Contact: Prof Bu'Hussain B Hayee, PHD FRCP
• Phone: 02032996044
• Email: b.hayee[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: May 31, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colo-rectal Cancer
• Colonic Adenoma
• Colonic Polyp
• Colonic Polyps

Intervention

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

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust	Medtronic, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	APC	Mean adenomas per colonoscopy (APC)	24 months
Secondary	Polyp characteristics	Polyp size (mm) and location (in colonic segments)	24 months
Secondary	Procedure time	Total procedure (insertion+withdrawal) and withdrawal time	24 months