Colonic NeoplasmsREVEALNCT05619614
The Influence of Artificial Intelligence (AI )Assisted Polyp Detection (Discovery System) on Visual Gaze Patterns During Real-time Colonoscopy
An observational study of Colonic Neoplasms, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
In this study, the investigators aim to assess the influence of a computer-aided detection (CADe) system on the visual gaze patterns of endoscopists in order to further understand the effect of AI during real-time colonoscopy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- eye-tracking glasses
- Type of treatment
- Medical device
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2024to 30 Nov 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults who are referred for regular care colonoscopy
Who may be able to join
- Referred for diagnostic, screening or surveillance colonoscopy
Who cannot join
- Therapeutic procedure
- Boston Bowel Prep Score (BBPS) score of <6
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud university medical center Nijmegen
Nijmegen, Gelderland, 6500 HB
About this study
Official title: The Influence of Artificial Intelligence (AI) Assisted Polyp Detection (Discovery System) on Visual Gaze Patterns During Real-time Colonoscopy
In this study, the investigators aim to assess the influence of a computer-aided detection (CADe) system on the visual gaze patterns of endoscopists in order to further understand the effect of AI during real-time colonoscopy.
- Conditions
- Colonic Neoplasms
- Being tested
- eye-tracking glasses
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye-tracking glassesDevice
endoscopists wear eye-tracking glasses during real-time colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Patients | Participating patients who undergo colonoscopy | |
| Endoscopists CADe | Physicians performing CADe colonoscopy Receives: Device: eye-tracking glasses | |
| Endoscopists CC | Physicians performing conventional colonoscopy Receives: Device: eye-tracking glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean gaze time per area of influence
Measured: End of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Jun 2024
- Primary completion1 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Utrecht University, Lund University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619614
- Sponsor's protocol ID
- 2022-13870
- Acronym
- REVEAL
- Status last verified
- Apr 2025
- First submitted
- 9 Nov 2022
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Artificial Intelligence (AI) Assisted Polyp Detection (Discovery System) on Visual Gaze Patterns During Real-time Colonoscopy
- ClinicalTrials.gov ID
- NCT05619614
- Acronym / sponsor ID
- REVEAL / 2022-13870
- Conditions
- Colonic Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Utrecht University, Lund University
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 17 Nov 2022 (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.
In this study, the investigators aim to assess the influence of a computer-aided detection (CADe) system on the visual gaze patterns of endoscopists in order to further understand the effect of AI during real-time colonoscopy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Participating patients who undergo colonoscopy |
| Endoscopists CADe | – | Device: eye-tracking glassesPhysicians performing CADe colonoscopy |
| Endoscopists CC | – | Device: eye-tracking glassesPhysicians performing conventional colonoscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults who are referred for regular care colonoscopy
Key inclusion criteria (1 listed)
- Referred for diagnostic, screening or surveillance colonoscopy
Key exclusion criteria (2 listed)
- Therapeutic procedure
- Boston Bowel Prep Score (BBPS) score of <6
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 |
|---|---|---|
| eye-tracking glassesendoscopists wear eye-tracking glasses during real-time colonoscopy | Device | Endoscopists CADe, Endoscopists CC |
Primary outcome
Mean gaze time per area of influence
Time frame: End of colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neoplasms, run by Radboud University Medical Center at 1 site in Netherlands.
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: finished, as of the sponsor's last update on 15 Aug 2025. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean gaze time per area of influence (time frame: End of colonoscopy). 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 15 Aug 2025.