Prospective evaluation of a new artificial intelligence system for the classification of colonic polyps.

Phase 4

• Conditions: D12; K63.5; Benign neoplasm of colon, rectum, anus and anal canal; Polyp of colon

• Registration Number: DRKS00028894
• Lead Sponsor: Krankenhaus der Barmherzigen Brüder Regensburg,Klinik für Gastroenterologie und interventionelle Endoskopie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-09
• Study Completion: 2022-08-25
• Results First Posted: 2023-09-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

ASA I to III,
completed 18th year of age,
diagnostic/therapeutic colonoscopy or presentation for polypectomy,
signed declaration of information and consent

Exclusion Criteria

Polyps >10mm,
chronic inflammatory bowel disease,
Coagulopathy or anticoagulant drugs that make biospy or poylpectomy impossible,
poor general condition (ASA IV or higher),
Pregnancy and lactation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of correctly classified polyps detected by the AI system (accuracy).<br><br>The polyp classification is documented during the colonoscopy using the case report form(CRF).<br>Later the result is compared with histology(gold standard).

Secondary Outcome Measures

Name	Time	Method
-The rate of polyps correctly classified by the endoscopists.<br>The visual classification is documented using the CRF.<br>Later compared with histology(gold standard).<br><br>-Influence of clinical experience of the investigators on classification results.<br>Clinical experience is documented using the CRF.