Skip to content

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

Prospective evaluation of a new "artificial intelligence" system for the classification of colonic polyps. - GI Genius CADx

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00028894
Enrollment
150
Registered
2022-05-09
Start date
2022-05-04
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

D12 K63.5

Interventions

Group 1: colonoscopy with AI System

Sponsors

Krankenhaus der Barmherzigen Brüder Regensburg,Klinik für Gastroenterologie und interventionelle Endoskopie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Contacts

Public ContactOliver Pech

Krankenhaus der Barmherzigen Brüder Regensburg,Klinik für Gastroenterologie und interventionelle Endoskopie

Oliver.Pech@Barmherzige-regensburg.de+49 (0)941 369 2051

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026