Skip to main content
OpenTrials
Completed

NCT Number: NCT04378660

Artificial Intelligence (AI) Validation Study for Polyp Detection

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Polyp of Colon Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artificial intelligence for polyp detection

Diagnostic Test

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

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

Registry information

Official study title

Artificial Intelligence Validation Trial for Polyp Detection: Pilot Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 7, 2020
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.