NCT05322993

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,034

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

January 22, 2026

Status Verified

September 1, 2025

Enrollment Period

3.6 years

First QC Date

April 4, 2022

Last Update Submit

January 21, 2026

Conditions

Colonic Polyp

Keywords

ColonoscopyArtificial intelligencePolyp detection

Outcome Measures

Primary Outcomes (2)

  • Polyp detection rate (PDR) with and without artificial intelligence (AI)

    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?

    Evaluate if there is an improved PDR after the use of AI

    18 months

Secondary Outcomes (2)

  • Withdrawal time

    18 months

  • Complications

    24 months

Study Arms (2)

With artificial intelligence (AI)

ACTIVE COMPARATOR

Use of GI Genius artificial intelligence device during colonoscopy.

Device: GI Genius

Without artificial intelligence

ACTIVE COMPARATOR

Use of standard colonoscopy equipment without GI Genius.

Device: Standard white light colonoscope

Interventions

Standard white light colonoscopeDEVICE

Standard colonoscopy.

Without artificial intelligence
GI GeniusDEVICE

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

With artificial intelligence (AI)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients coming to outpatient clinics to perform colonoscopies

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Haraldsplass Deaconess Hospital

Bergen, Vestland, 5009, Norway

Location

Haukeland University Hospital

Bergen, Vestland, 5021, Norway

Location

Kanalspesialistene AS

Bergen, Vestland, 5068, Norway

Location

Related Links

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Roald F. Havre, Professor

    Helse Bergen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: Endoscopists will perform colonoscopies in three consecutive phases; 1. without artificial intelligence (AI), 2. with AI, 3. without (AI).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 12, 2022

Study Start

November 19, 2021

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

January 22, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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

Locations

NO(3)