NCT05619614

Brief Summary

In this study, the investigators aim to assess the influence of a computer-aided detection (CADe) system on the visual gaze patterns of endoscopists in order to further understand the effect of AI during real-time colonoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
1.5 years until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

August 15, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

November 9, 2022

Last Update Submit

August 12, 2025

Conditions

Colonic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Mean gaze time per area of influence

    End of colonoscopy

Study Arms (3)

Patients

Participating patients who undergo colonoscopy

Endoscopists CADe

Physicians performing CADe colonoscopy

Device: eye-tracking glasses

Endoscopists CC

Physicians performing conventional colonoscopy

Device: eye-tracking glasses

Interventions

eye-tracking glassesDEVICE

endoscopists wear eye-tracking glasses during real-time colonoscopy

Endoscopists CADeEndoscopists CC

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults who are referred for regular care colonoscopy

You may qualify if:

  • Referred for diagnostic, screening or surveillance colonoscopy

You may not qualify if:

  • Therapeutic procedure
  • Boston Bowel Prep Score (BBPS) score of \<6

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud university medical center Nijmegen

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 17, 2022

Study Start

June 1, 2024

Primary Completion

November 1, 2024

Study Completion

November 30, 2024

Last Updated

August 15, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)