NCT04378660

Brief Summary

Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
357

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

October 30, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
Last Updated

May 7, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

April 20, 2020

Last Update Submit

May 5, 2020

Conditions

Polyp of Colon

Keywords

Colonic polypArtificial intelligenceSecond observer

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of the novel AI system compared to endoscopic diagnosis as gold standard

    Determination of the diagnostic accuracy of the novel AI system as second observer

    4 months

Secondary Outcomes (1)

  • Endoscopist's polyp miss rate as number of extra AI detections

    4 months

Study Arms (1)

Intervention arm

EXPERIMENTAL

Colonoscopy with AI

Diagnostic Test: Artificial intelligence for polyp detection

Interventions

Artificial intelligence for polyp detectionDIAGNOSTIC_TEST

Colonoscopy enriched with artificial intelligence tool developed for polyp detection, implemented as a second observer

Intervention arm

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years
  • Diagnostic or screening colonoscopy
  • Therapeutic colonoscopy

You may not qualify if:

  • Inability to give informed consent by the patient or legal representative
  • \< 18 years old
  • Any contraindication for colonoscopy or biopsies of the colon
  • Uncontrolled coagulopathy
  • Confirmed diagnosis of inflammatory bowel disease
  • Short bowel or ileostomy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

MeSH Terms

Conditions

Colonic Polyps

Interventions

Artificial Intelligence

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical Concepts

Study Officials

  • Raf Bisschops

    UZ Leuven

    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

Study Record Dates

First Submitted

April 20, 2020

First Posted

May 7, 2020

Study Start

October 30, 2019

Primary Completion

April 18, 2020

Study Completion

April 18, 2020

Last Updated

May 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

We don't share any patient information with other researchers, nor when it's anonymized

Locations

BE(1)