Artificial Intelligence (AI) Validation Study for Polyp Detection

May 5, 2020 updated by: Universitaire Ziekenhuizen KU Leuven

Artificial Intelligence Validation Trial for Polyp Detection: Pilot Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an investigator-initiated multicentre non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided diagnostic (CAD) tool in polyp detection implemented as second observer during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Patients referred for a screening surveillance or therapeutic colonoscopy will undergo a colonoscopy performed by an endoscopist with moderate to high adenoma detection rate (ADR > 20% and < 50%) while a second observer will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows (1) true positive, (2) false negative, (3) other positive and (4) obvious false positive. When a doubtful detection is made by the AI-system, the second observer will ask to re-evaluate the indicated region. When the detection is clear, the endoscopist and second observer do not communicate. The entire procedure is recorded.

Study Type

Interventional

Enrollment (Actual)

357

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

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • University Hospitals Leuven

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
Colonoscopy with AI
Diagnostic test: Artificial intelligence for polyp detection
Colonoscopy enriched with artificial intelligence tool developed for polyp detection, implemented as a second observer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of the novel AI system compared to endoscopic diagnosis as gold standard
Time Frame: 4 months
Determination of the diagnostic accuracy of the novel AI system as second observer
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopist's polyp miss rate as number of extra AI detections
Time Frame: 4 months
Determination of the AI system's precision and extra value as second observer
4 months

Collaborators and Investigators

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

Sponsor

Universitaire Ziekenhuizen KU Leuven

Collaborators

Nuovo Regina Margherita Hospital, Rome, Italy
Universitäts Medizin, Mainz, Germany

Investigators

  • Principal Investigator: Raf Bisschops, Uz Leuven

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)

October 30, 2019

Primary Completion (Actual)

April 18, 2020

Study Completion (Actual)

April 18, 2020

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

May 5, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

May 7, 2020

Last Update Submitted That Met QC Criteria

May 5, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s59405

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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