NCT05754229

Brief Summary

The goal of this substudy is to investigate the accuracy of a computer-aided polyp characterization (CADx) system. The main question\[s\] it aims to answer are: • How high is the specificity of the AI system when characterizing colorectal polyps Participants will receive a standard colonoscopy, assisted by the artificial intelligence (AI) assisted system GI Genius. Researchers will compare the AI system´s characterization with the histopathology to see how accurate the system is.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
395

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

4 active sites

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 3, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 3, 2023

Last Update Submit

February 12, 2024

Conditions

Colorectal CancerColorectal AdenomaColorectal Neoplasms

Keywords

Artificial intelligence-assisted colonoscopyComputer-aided polyp characterizationColorectal adenoma

Outcome Measures

Primary Outcomes (4)

  • True positive findings: Adenomas (histopathologically verified) characterized as adenomas by the AI system

    Data from the AI system will be compared with the histopathological data for each removed polyp

    5 Months

  • True negative findings: Non-adenomas (histopathologically verified) characterized as non-adenomas by the AI system

    Data from the AI system will be compared with the histopathological data for each removed polyp

    5 Months

  • False positive findings: Non-adenomas (histopathologically verified) characterized as adenomas by the AI system

    Data from the AI system will be compared with the histopathological data for each removed polyp

    5 Months

  • False negative findings: Adenomas (histopathologically verified) characterized as non-adenomas by the AI system

    Data from the AI system will be compared with the histopathological data for each removed polyp

    5 Months

Study Arms (1)

AI-assisted colonoscopy

OTHER

The patients in the intervention group will receive an AI-assisted colonoscopy (AIC) using the computer-aided polyp detection and characterization (CADe and CADx) GI Genius (Medtronic).

Device: AI-assisted colonoscopy

Interventions

AI-assisted colonoscopyDEVICE

The patients will receive an AI-assisted colonoscopy (AIC) using the computer-aided polyp detection and characterization (CADe and CADx) GI Genius (Medtronic).

AI-assisted colonoscopy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Referred for screening colonoscopy due to a positive faecal immunochemical test (FIT) or for
  • Diagnostic colonoscopy due to symptoms/signs or
  • Post-polypectomy surveillance colonoscopy (only patients who had all detected polyps removed in the previous colonoscopy)

You may not qualify if:

  • Referral for removal of previous detected polyps
  • Emergency colonoscopy
  • Control colonoscopy due to inflammatory bowel disease (IBD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Holbæk Hospital

Holbæk, 4300, Denmark

Location

Zealand University Hospital

Køge, 4600, Denmark

Location

Nykøbing Falster County Hospital

Nykøbing Falster, 4800, Denmark

Location

Næstved Hospital

Næstved, 4700, Denmark

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Ronja Lagström, MD

    Zealand University Hospital, Køge

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, DMSc

Study Record Dates

First Submitted

February 3, 2023

First Posted

March 3, 2023

Study Start

October 1, 2022

Primary Completion

March 3, 2023

Study Completion

September 30, 2025

Last Updated

February 13, 2024

Record last verified: 2024-02

Locations

DK(4)