An observational study in Colonic Polyp, Colonic Adenoma and Colo-rectal Cancer, sponsored by King's College Hospital NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by King's College Hospital NHS Trust · Observational
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
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.
377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 411 across 115 observational studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →King's College Hospital NHS Trust is the lead sponsor of 171 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Unselected patients scheduled for diagnostic colonoscopy
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Exclusion Criteria:
Patient ≥18 years old, with capacity to consent, scheduled for diagnostic colonoscopy
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
Also known as: CADe
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).
Time frame: 24 months
APC
Mean adenomas per colonoscopy (APC)
Time frame: 24 months
Polyp characteristics
Polyp size (mm) and location (in colonic segments)
Time frame: 24 months
Procedure time
Total procedure (insertion+withdrawal) and withdrawal time
Time frame: 24 months
Started Oct 2023 (actual). Primary completion is estimated for Jan 2025, 14 months after the start.
Of 52 non-industry observational studies under Colonic Polyps, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 90. This study's planned 14 months is below that.
Counting every sponsor, half of 62 studies reached it within 19 months; a quarter within 10 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
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