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Trial Title:
Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy
NCT ID:
NCT05870332
Condition:
Colonic Polyp
Colonic Adenoma
Colo-rectal Cancer
Conditions: Official terms:
Adenoma
Colonic Polyps
Conditions: Keywords:
Artificial Intelligence
Computer assisted detection (CADe)
Colorectal cancer
Adenoma Detection Rate (ADR)
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
GI Genius (GIG)
Description:
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
Arm group label:
All patients
Other name:
CADe
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.
Criteria for eligibility:
Study pop:
Unselected patients scheduled for diagnostic colonoscopy
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
King's College Hospital NHS Foundation Trust
Address:
City:
London
Zip:
SE5 9RS
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Alena B Marynina
Phone:
+442032996044
Email:
alena.marynina@nhs.net
Contact backup:
Last name:
Olaolu Olabintan
Phone:
07939 056819
Email:
olaolu.olabintan@nhs.net
Investigator:
Last name:
Bu'Hussain B Hayee, MBBS, PhD
Email:
Principal Investigator
Start date:
October 16, 2023
Completion date:
May 31, 2025
Lead sponsor:
Agency:
King's College Hospital NHS Trust
Agency class:
Other
Collaborator:
Agency:
Medtronic
Agency class:
Industry
Collaborator:
Agency:
National Institute for Health Research, United Kingdom
Agency class:
Other
Source:
King's College Hospital NHS Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05870332
