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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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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 Geniusâ„¢ (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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Patient ≥18 years old, with capacity to consent, scheduled for diagnostic colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GI Genius (GIG) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| APC | Mean adenomas per colonoscopy (APC) | 24 months |
| Polyp characteristics | Polyp size (mm) and location (in colonic segments) | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Unselected patients scheduled for diagnostic colonoscopy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof Bu'Hussain B Hayee, PHD FRCP | Contact | 02032996044 | b.hayee@nhs.net | |
| Dr Olaolu Olabintan, MBBS MRCP | Contact | 07939056819 | olaolu.olabintan@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Prof Bu'Hussain B Hayee | King's College Hospital NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College Hospital NHS Foundation Trust | Recruiting | London | SE5 9RS | United Kingdom |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D003110 | Colonic Neoplasms |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Procedure time | Total procedure (insertion+withdrawal) and withdrawal time | 24 months |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |