Real-Time Non-Invasive Diagnosis of Eosinophilic Nasal Polyps in Adults Using High-Sensitivity Spectroscopy

What this Trial Is About

Chronic rhinosinusitis with nasal polyps CRSwNP is a common condition causing nasal congestion, discharge, and reduced sense of smell, significantly impacting quality of life. A subtype called eosinophilic CRSwNP eCRSwNP is challenging to treat and often recurs after surgery. Currently, diagnosis of eCRSwNP requires tissue samples collected after surgery, leading to delays and possibly unnecessary operations. Researchers are evaluating a new, non-invasive diagnostic system using advanced spectral technology to detect natural fluorescence markers inside eosinophils in nasal polyps, aiming to identify eCRSwNP before surgery. The study involves patients with CRSwNP undergoing a non-invasive test using a high-sensitivity spectroscopy system with autofluorescence. A thin probe emits safe laser light at nasal polyp tissue to capture specific fluorescence signals, allowing real-time classification of eosinophilic versus non-eosinophilic polyps. Tissue samples will also be obtained by biopsy or surgery for confirmation. Safety is monitored by checking for mucosal irritation, swelling, or bleeding within 24 hours, with pain levels recorded. Participants will receive the diagnostic test once during the initial visit. Researchers will compare the devices diagnosis with the gold standard histopathology over up to 14 days. They will assess diagnostic accuracy, including sensitivity and specificity, and monitor adverse events. The study starts in August 2025 and continues until June 2028, aiming to improve personalized treatment choices, reduce unnecessary surgeries, and lower recurrence rates for patients with CRSwNP.

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