Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy

NANot yet recruitingINTERVENTIONAL
Enrollment

353

Participants

Timeline

Start Date

August 26, 2025

Primary Completion Date

January 1, 2028

Study Completion Date

June 1, 2028

Conditions
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Interventions
DIAGNOSTIC_TEST

High-Sensitivity Spectroscopy with Autofluorescence for eCRSwNP Diagnosis

This intervention employs a non-invasive diagnostic procedure using a high-sensitivity spectroscopy system with autofluorescence to identify eosinophilic chronic rhinosinusitis with nasal polyps (eCRSwNP). A specialized thin probe, guided by an endoscopic light source, contacts nasal polyp tissue to emit a proprietary wavelength laser light, exciting fluorescent substances (primarily flavin adenine dinucleotide, FAD). The probe captures autofluorescence signals at a specific emission wavelength, and signal intensity analysis distinguishes eosinophilic from non-eosinophilic polyps in real-time. Unlike invasive histopathological diagnosis via biopsy or surgery, this method enables rapid preoperative typing. Conducted once at the initial visit, results are validated against post-biopsy/surgical histopathology (gold standard) to assess diagnostic accuracy (sensitivity ≥90%, specificity ≥85%). Safety is monitored for adverse events like mucosal irritation or bleeding within 24 hours.

All Listed Sponsors
lead

The Affiliated Hospital of Qingdao University

OTHER

NCT07125586 - Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy | Biotech Hunter | Biotech Hunter