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NCT05870332 | Recruiting | Colonic Polyp


Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy
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

Condition or disease

Colonic Polyp

Colonic Adenoma

Colorectal Cancer

Intervention/treatment

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
Estimated Enrollment : 4000 participants
Official Title : Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy
Actual Study Start Date : October 16, 2023
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : May 31, 2025

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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

Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy

Location Details


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Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United Kingdom,

King's College Hospital NHS Foundation Trust

London, United Kingdom, SE5 9RS

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