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Improving Polyp Detection Rate by Artificial Intelligence in Colonoscopy

Improving Polyp Detection Rate by Artificial Intelligence in Colonoscopy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05322993
Enrollment
5034
Registered
2022-04-12
Start date
2021-11-19
Completion date
2025-06-30
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Polyp

Keywords

Colonoscopy, Artificial intelligence, Polyp detection

Brief 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.

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.

Interventions

DEVICEGI Genius

The use of artificial intelligence during colonoscopy to improve polyp detection.

DEVICEStandard white light colonoscope

Standard colonoscopy.

Sponsors

Haraldsplass Deaconess Hospital
Lead SponsorOTHER
Haukeland University Hospital
CollaboratorOTHER
European Society of Gastrointestinal Endoscopy
CollaboratorOTHER
Kanalspesialistene AS
CollaboratorUNKNOWN

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Endoscopists will perform colonoscopies in three consecutive phases; 1. without artificial intelligence (AI), 2. with AI, 3. without (AI).

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Patients coming to outpatient clinics to perform colonoscopies

Exclusion criteria

* Total colectomy * Reservation against registration in Gastronet, the national quality register for colonoscopy in Norway

Design outcomes

Primary

MeasureTime frameDescription
Polyp detection rate (PDR) with and without artificial intelligence (AI)18 monthsEvaluate the PDR with and without the use of GI Genus artificial intelligence
PDR after the use of AI, is there a learning effect?18 monthsEvaluate if there is an improved PDR after the use of AI

Secondary

MeasureTime frameDescription
Withdrawal time18 monthsTo evaluate if the withdrawal time is influenced by the use of artificial intelligence
Complications24 monthsTo evaluate if there are more registered complications with the use of AI

Countries

Norway

Contacts

STUDY_DIRECTORRoald F. Havre, Professor

Helse Bergen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026