Clinical vAliDation of ARTificial Intelligence in POlyp Detection

Summary

This study is an open label, unblinded, non-randomized interventional study, comparing the investigational artificial intelligence tool with the current "gold standard": Data acquisition will be obtained during one scheduled colonoscopic procedure by a trained endoscopist. During insertion, no action will be taken, colonoscopy is performed following the standard of care. Once withdrawal is started, a second observer (not a trained endoscopist but person trained in polyp recognition) will start the bedside Artificial intelligence (AI) tool, connected to the endoscope's tower, for detection. This second observer is trained in assessing endoscopic images to define the AI tool's outcome. Due to the second observer watching the separate AI screen, the endoscopist is blinded of the AI outcome. When a detection is made by the AI system that is not recognized by the endoscopist, the endoscopist will be asked to relocate that same detection and to reassess the lesion and the possible need of therapeutic action. All detections are separately counted and categorized by the second observer. All polyp detections will be removed following standard of care for histological assessment. The entire colonoscopic procedure is recorded via a separate linked video-recorder.

Conditions

• Polyp of Colon

Interventions

DEVICE

artificial intelligence image processing

Patients will undergo a standard colonoscopy performed by a trained endoscopist. A second observer, who is not a trained endoscopist, 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 or (3) false positive.

Sponsors & Collaborators

• Nuovo Regina Margherita Hospital, Rome, Italy

  collaborator UNKNOWN

• Krankenhaus Barmherzige Brüder, Regensburg, Germany

  collaborator UNKNOWN

• Centre Hospitalier Universitaire de Nantes, Nantes, France

  collaborator UNKNOWN

• Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie, Warschau, Poland

  collaborator UNKNOWN

• Spire Portsmouth Hospital, Portsmouth, United Kingdom

  collaborator UNKNOWN

• University Medical Center, Amsterdam, The Netherlands

  collaborator UNKNOWN

• University Hospitals Ghent, Ghent, Belgium

  collaborator UNKNOWN

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Raf Bisschops, MD,PhD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-10-13

Primary Completion

2022-10-28

Completion

2022-11-29

Countries

• Belgium

Study Locations