Colonic PolypNCT05322993
Improving Polyp Detection Rate by Artificial Intelligence in Colonoscopy
A study testing GI Genius and Standard white light colonoscope in people with Colonic Polyp, run by Haraldsplass Deaconess Hospital at 3 sites in Norway.
Trial summary
The aim of this study is to investigate if the use of artificial intelligence (AI) in colonoscopy improves the polyp detection rate, and if the use of AI has a learning effect. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyp
- What is being tested?
- GI Genius and Standard white light colonoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,034 participants
- Where
- 3 sitesNorway
- Study dates
- 19 Nov 2021to 30 Jun 2025
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients coming to outpatient clinics to perform colonoscopies
Who cannot join
- Total colectomy
- Reservation against registration in Gastronet, the national quality register for colonoscopy in Norway
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Haraldsplass Deaconess Hospital
Bergen, Vestland, 5009
Haukeland University Hospital
Bergen, Vestland, 5021
Kanalspesialistene AS
Bergen, Vestland, 5068
About this study
The aim of this study is to investigate if the use of artificial intelligence (AI) in colonoscopy improves the polyp detection rate, and if the use of AI has a learning effect.
Read the detailed description
The endoscopists will use GI Genius from Medtronic, a device that uses artificial intelligence (AI) based on machine learning to detect polyps in the colon in real time during colonoscopy. The device interprets the endoscopy pictures and superimposes possible polyps with frames.
The patients will be included in regular outpatient clinics in Western Norway. The endoscopists will be divided into groups depending on their experience. The endoscopists will perform colonoscopies in three phases; (1) before the use of AI, (2) during the use of AI and (3) after the use of AI. The investigators will then evaluate the polyp detection rate (PDR) in the three phases to see if AI increases PDR, and if there is a learning effect on PDR after the use of AI. The investigators will also evaluate if there is a difference in the learning-effect from AI-use depending on if the endoscopist is experienced or inexperienced.
The PDR's are registered as part of Norway's national quality register of colonoscopy, Gastronet. The data registered in Gastronet can also help the investigators evaluate other outcomes such as withdrawal time, bowel preparation, patient reported pain, patient satisfaction and complications.
- Conditions
- Colonic Polyp
- Being tested
- GI Genius, Standard white light colonoscope
- Keywords
- Colonoscopy, Artificial intelligence, Polyp detection
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI GeniusDevice
The use of artificial intelligence during colonoscopy to improve polyp detection.
Standard white light colonoscopeDevice
Standard colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| With artificial intelligence (AI) | Active comparator | Use of GI Genius artificial intelligence device during colonoscopy. Receives: Device: GI Genius |
| Without artificial intelligence | Active comparator | Use of standard colonoscopy equipment without GI Genius. Receives: Device: Standard white light colonoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polyp detection rate (PDR) with and without artificial intelligence (AI)
Evaluate the PDR with and without the use of GI Genus artificial intelligence
Measured: 18 months
PDR after the use of AI, is there a learning effect?
Evaluate if there is an improved PDR after the use of AI
Measured: 18 months
Secondary outcomes (2)
Withdrawal time
To evaluate if the withdrawal time is influenced by the use of artificial intelligence
Measured: 18 months
Complications
To evaluate if there are more registered complications with the use of AI
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 posted12 Apr 2022
- Study start19 Nov 2021
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Endoscopists will perform colonoscopies in three consecutive phases; 1. without artificial intelligence (AI), 2. with AI, 3. without (AI).
- Masking
- None (open label)
- Enrolment
- 5,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haraldsplass Deaconess Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, European Society of Gastrointestinal Endoscopy, Kanalspesialistene AS
- Responsible party
- Sponsor
- Investigators
- Roald F. Havre, Professor, Study director, Helse Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322993
- Sponsor's protocol ID
- REK 275068
- Status last verified
- Sep 2025
- First submitted
- 4 Apr 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no specific plan to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Polyp Detection Rate by Artificial Intelligence in Colonoscopy
- ClinicalTrials.gov ID
- NCT05322993
- Acronym / sponsor ID
- REK 275068
- Conditions
- Colonic Polyp
- Keywords
- Colonoscopy, Artificial intelligence, Polyp detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,034 participants (actual)
- Lead sponsor
- Haraldsplass Deaconess HospitalUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, European Society of Gastrointestinal Endoscopy, Kanalspesialistene AS
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 12 Apr 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.
The aim of this study is to investigate if the use of artificial intelligence (AI) in colonoscopy improves the polyp detection rate, and if the use of AI has a learning effect.
Detailed description
The endoscopists will use GI Genius from Medtronic, a device that uses artificial intelligence (AI) based on machine learning to detect polyps in the colon in real time during colonoscopy. The device interprets the endoscopy pictures and superimposes possible polyps with frames.
The patients will be included in regular outpatient clinics in Western Norway. The endoscopists will be divided into groups depending on their experience. The endoscopists will perform colonoscopies in three phases; (1) before the use of AI, (2) during the use of AI and (3) after the use of AI. The investigators will then evaluate the polyp detection rate (PDR) in the three phases to see if AI increases PDR, and if there is a learning effect on PDR after the use of AI. The investigators will also evaluate if there is a difference in the learning-effect from AI-use depending on if the endoscopist is experienced or inexperienced.
The PDR's are registered as part of Norway's national quality register of colonoscopy, Gastronet. The data registered in Gastronet can also help the investigators evaluate other outcomes such as withdrawal time, bowel preparation, patient reported pain, patient satisfaction and complications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Endoscopists will perform colonoscopies in three consecutive phases; 1. without artificial intelligence (AI), 2. with AI, 3. without (AI).
| Arm | Type | Receives |
|---|---|---|
| With artificial intelligence (AI) | Active comparator | Device: GI GeniusUse of GI Genius artificial intelligence device during colonoscopy. |
| Without artificial intelligence | Active comparator | Device: Standard white light colonoscopeUse of standard colonoscopy equipment without GI Genius. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients coming to outpatient clinics to perform colonoscopies
Key exclusion criteria (2 listed)
- Total colectomy
- Reservation against registration in Gastronet, the national quality register for colonoscopy in Norway
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 GeniusThe use of artificial intelligence during colonoscopy to improve polyp detection. | Device | With artificial intelligence (AI) |
| Standard white light colonoscopeStandard colonoscopy. | Device | Without artificial intelligence |
Primary outcome
Polyp detection rate (PDR) with and without artificial intelligence (AI)
Time frame: 18 months
Evaluate the PDR with and without the use of GI Genus artificial intelligence
PDR after the use of AI, is there a learning effect?
Time frame: 18 months
Evaluate if there is an improved PDR after the use of AI
2 secondary outcomes
Withdrawal time
Time frame: 18 months
Complications
Time frame: 24 months
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 22 Jan 2026.
- Gastronet, the national quality register of colonoscopiesLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no specific plan to share IPD with other researchers.
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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.
Roald F. Havre, Professor study director
Helse Bergen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GI Genius and Standard white light colonoscope in people with Colonic Polyp, run by Haraldsplass Deaconess Hospital at 3 sites in Norway.
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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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?
Polyp detection rate (PDR) with and without artificial intelligence (AI) (time frame: 18 months). The study lists 2 primary outcomes in all. 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 22 Jan 2026.