Actively Recruiting
Evaluation of a Real-Time Diagnostic System Using High-Sensitivity Spectroscopy for Eosinophilic Nasal Polyps in Chronic Rhinosinusitis with Nasal Polyps
Led by The Affiliated Hospital of Qingdao University · Updated on 2025-12-30
353
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
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 device's 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.
CONDITIONS
Brief Title
Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 18 to 65 years old
- Diagnosed with chronic rhinosinusitis with nasal polyps by nasal endoscopy, CT, or MRI according to EPOS 2020 criteria
- Normal blood clotting function (prothrombin time, activated partial thromboplastin time, and platelet count within normal range)
- No severe heart or lung problems affecting tolerance of anesthesia and surgery
- Women of childbearing age agree to use appropriate contraception during the study and for 4 weeks after
- Able to comply with study procedures and voluntarily sign informed consent
You will not qualify if you...
- Nasal or sinus diseases other than chronic rhinosinusitis, such as nasal tumors, fungal sinusitis, or nasal deformities from trauma
- Blood clotting problems, immune deficiencies, use of blood thinners at visit, or menstruation for females
- Use of oral glucocorticoids within 1 month before visit
- History of nasal endoscopic surgery or nasal radiotherapy
- Pregnant or breastfeeding women, or those with severe uncontrolled diseases like high blood pressure, diabetes, liver or kidney problems
- Incomplete clinical or follow-up data
- Any other condition making participation unsuitable as judged by researchers
- Poor compliance with treatment or study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo a non-invasive diagnostic procedure using high-sensitivity spectroscopy with autofluorescence to identify eosinophilic nasal polyps in real-time.
1 baseline visit (in-person)
Duration - 1 day
Participants are monitored for safety by assessing mucosal irritation, swelling, bleeding, and pain within 24 hours after the diagnostic procedure.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266003
Actively Recruiting
Research Team
Y
Yan Jiang, MD
S
Shunke Li, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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