Colonic PolypNAIADNCT05870332
Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy
An observational study of Colonic Polyp and Colonic Adenoma, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp, Colonic Adenoma, Colo-rectal Cancer
- What is being tested?
- GI Genius (GIG)
- Type of treatment
- Medical device
- How many people
- 4,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Oct 2023to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Unselected patients scheduled for diagnostic colonoscopy
Who may be able to join
- Any patient aged 18-85 scheduled for colonoscopy by current NHSE / British Society of Gastroenterology criteria
Who cannot join
- Colonoscopy being performed for polyp surveillance
- Unable to provide informed, written consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Alena B Marynina, +442032996044, alena.marynina@nhs.net
Olaolu Olabintan, 07939 056819, olaolu.olabintan@nhs.net
About this study
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
Read the 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.
- Conditions
- Colonic Polyp, Colonic Adenoma, Colo-rectal Cancer
- Being tested
- GI Genius (GIG)
- Keywords
- Artificial Intelligence, Computer assisted detection (CADe), Colorectal cancer, Adenoma Detection Rate (ADR)
- Medical subject headings
- Colonic Polyps, Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI Genius (GIG)Device
Also called CADe
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
| Study group | Role | What they receive |
|---|---|---|
| All patients | Patient ≥18 years old, with capacity to consent, scheduled for diagnostic colonoscopy Receives: Device: GI Genius (GIG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24 months
Secondary outcomes (3)
APC
Mean adenomas per colonoscopy (APC)
Measured: 24 months
Polyp characteristics
Polyp size (mm) and location (in colonic segments)
Measured: 24 months
Procedure time
Total procedure (insertion+withdrawal) and withdrawal time
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start16 Oct 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Prof Bu'Hussain B Hayee, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870332
- Sponsor's protocol ID
- 292323
- Acronym
- NAIAD
- Status last verified
- Mar 2024
- First submitted
- 2 May 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nationwide Study of Artificial Intelligence in Adenoma Detection for Colonoscopy
- ClinicalTrials.gov ID
- NCT05870332
- Acronym / sponsor ID
- NAIAD / 292323
- Conditions
- Colonic Polyp, Colonic Adenoma, Colo-rectal Cancer
- Keywords
- Artificial Intelligence, Computer assisted detection (CADe), Colorectal cancer, Adenoma Detection Rate (ADR)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Medtronic, National Institute for Health Research, United Kingdom
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Device: GI Genius (GIG)Patient ≥18 years old, with capacity to consent, scheduled for diagnostic colonoscopy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Unselected patients scheduled for diagnostic colonoscopy
Key inclusion criteria (1 listed)
- Any patient aged 18-85 scheduled for colonoscopy by current NHSE / British Society of Gastroenterology criteria
Key exclusion criteria (2 listed)
- Colonoscopy being performed for polyp surveillance
- Unable to provide informed, written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GI Genius (GIG)Also: CADeGIG 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 | Device | All patients |
Primary outcome
CADe-ADR in real world practice
Time frame: 24 months
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).
3 secondary outcomes
APC
Time frame: 24 months
Polyp characteristics
Time frame: 24 months
Procedure time
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Bu'Hussain B Hayee principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Polyp and Colonic Adenoma, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prof Bu'Hussain B Hayee, PHD FRCP (02032996044, b.hayee@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CADe-ADR in real world practice (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.