Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy
NCT ID: NCT05870332
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4000 participants
OBSERVATIONAL
2023-10-16
2025-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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All patients
Patient ≥18 years old, with capacity to consent, scheduled for diagnostic colonoscopy
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Unable to provide informed, written consent
18 Years
85 Years
ALL
Yes
Sponsors
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Medtronic
INDUSTRY
National Institute for Health Research, United Kingdom
OTHER_GOV
King's College Hospital NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Prof Bu'Hussain B Hayee
Role: PRINCIPAL_INVESTIGATOR
King's College Hospital NHS Trust
Locations
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King's College Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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292323
Identifier Type: -
Identifier Source: org_study_id
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