Improving Polyp Detection Rate by Artificial Intelligence in Colonoscopy

January 21, 2026 updated by: Haraldsplass Deaconess Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5034

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Vestland
      • Bergen, Vestland, Norway, 5021
        • Haukeland University Hospital
      • Bergen, Vestland, Norway, 5009
        • Haraldsplass Deaconess Hospital
      • Bergen, Vestland, Norway, 5068
        • Kanalspesialistene AS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: With artificial intelligence (AI)
Use of GI Genius artificial intelligence device during colonoscopy.
Device: GI Genius
The use of artificial intelligence during colonoscopy to improve polyp detection.
Active Comparator: Without artificial intelligence
Use of standard colonoscopy equipment without GI Genius.
Device: Standard white light colonoscope
Standard colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months
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
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Withdrawal time
Time Frame: 18 months
To evaluate if the withdrawal time is influenced by the use of artificial intelligence
18 months
Complications
Time Frame: 24 months
To evaluate if there are more registered complications with the use of AI
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haraldsplass Deaconess Hospital

Collaborators

Haukeland University Hospital
Kanalspesialistene AS
European Society of Gastrointestinal Endoscopy

Investigators

  • Study Director: Roald F. Havre, Professor, Helse Bergen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2021

Primary Completion (Actual)

June 30, 2025

Study Completion (Actual)

June 30, 2025

Study Registration Dates

First Submitted

April 4, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 12, 2022

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK 275068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no specific plan to share IPD with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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