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NCT04442607: CAD-ARTIPOD

Clinical vAliDation of ARTificial Intelligence in POlyp Detection

Completed NA Last updated 30 November 2022
What this trial tests

NA trial testing artificial intelligence image processing in Polyp of Colon in 856 participants. Completed in 29 November 2022.

Timeline
13 October 2020
Primary endpoint
28 October 2022
29 November 2022

Quick facts

Lead sponsorUniversitaire Ziekenhuizen KU Leuven
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment856
Start date13 October 2020
Primary completion28 October 2022
Estimated completion29 November 2022
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

40 and older, any sex, with Polyp of Colon. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. UEG Week 2024 Oral Presentations
    · 2024

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Other recruiting trials for Polyp of Colon

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Other Universitaire Ziekenhuizen KU Leuven trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04442607.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing