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Relation between Diagnostic Accuracy and Sharpness of ENT endoscopes

Relation between Diagnostic Accuracy and Sharpness of ENT endoscopes - DAS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON57825
Enrollment
60
Registered
2024-06-03
Start date
2025-03-13
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Late radiation effects, leukoplakia, papilloma, squamous cell carcinoma and healthy vocal cords . Radiotherapy, leukoplakia, papilloma, cancer and healthy vocal cords.

Interventions

Image sharpness of nasopharygoscopes.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The aim is to include 60 study participants in the following five different categories:   - Squamous cell carcinoma on the vocal cords (n=8) - leukoplakia on the vocal cords (n=8) - late radiation effects on vocal cords (n=8) - papilloma on vocal cords (n=8) - healthy vocal cords (n=8). The number of study participants (60) is larger than the minimal required number of participants (40) to compensate for recorded video's that appear to be unsuitable for this research project. Older than the age of 18 years and competent.  Although pregnant or breastfeeding woman may be included, there is no need to  ask or register anything about pregnancy or breastfeeding. There is no reason  to exclude participants elder than the age of 64 years, but participants should  understand the general concept and the additional burden of this study and  consent.

Exclusion criteria

Exclusion criteria: Below the age of 18 years or incapable of giving informed consent.

Design outcomes

Primary

MeasureTime frame
Image sharpness expressed as MTF50. Diagnostic accuracy expressed as the percentage of videos assessed correctly.

Secondary

MeasureTime frame
- sensitivity, specificity, positve predictive value and negative predictive value per pathology (4 pathologies). - sensitivity, specificity, positve predictive value and negative predictive value disease versus non-disease.

Countries

Netherlands

Contacts

Public ContactG Geleijnse

Erasmus MC, Universitair Medisch Centrum Rotterdam

g.geleijnse@erasmusmc.nl0622634820

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 19, 2026