Real-time detection of eosinophilic nasal polyps using high-sensitivity spectroscopy
Evaluation of Efficacy and Safety of a Real-time Typing Diagnosis System for Eosinophilic Nasal Polyps Based on High-sensitivity Spectroscopy Technology
NA · The Affiliated Hospital of Qingdao University · NCT07125586
This will test a non-invasive light-based device that shines a safe light into the nose to quickly find eosinophilic nasal polyps in adults with chronic rhinosinusitis with nasal polyps.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 353 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The Affiliated Hospital of Qingdao University (other) |
| Locations | 1 site (Qingdao, Shandong) |
| Trial ID | NCT07125586 on ClinicalTrials.gov |
What this trial studies
This interventional study uses a high-sensitivity spectroscopy system that detects natural autofluorescence from eosinophils in nasal polyp tissue to provide a real-time diagnostic readout. The device is applied to nasal tissue preoperatively and fluorescence spectra are analyzed to identify the eosinophilic subtype of CRSwNP. Results will be compared with current reference methods that require tissue sampling to determine diagnostic accuracy and record safety outcomes. The enrolled population includes adults aged 18–65 with CRSwNP confirmed by endoscopy, CT, or MRI.
Who should consider this trial
Good fit: Adults aged 18–65 with CRSwNP diagnosed by nasal endoscopy, CT, or MRI who are able to tolerate anesthesia/surgery and have normal coagulation are the ideal candidates.
Not a fit: Patients with other nasal or paranasal diseases (for example nasal tumors or fungal sinusitis), coagulation disorders, severe cardiopulmonary comorbidity, pregnant women, or those outside the 18–65 age range are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, the device could let doctors identify the eosinophilic subtype before surgery, enabling faster personalized treatment decisions and reducing unnecessary operations.
How similar studies have performed: Spectroscopy and autofluorescence approaches have shown promise in other diagnostic applications, but applying high-sensitivity autofluorescence specifically to detect eosinophilic nasal polyps is a novel application with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male and female subjects aged 18 to 65 years old 2. Subjects diagnosed with CRSwNP by nasal endoscopy, CT, or MRI preoperatively (in accordance with the diagnostic criteria of EPOS 2020) 3. Normal coagulation function (prothrombin time \[PT\], activated partial thromboplastin time \[APTT\], and platelet count are within the normal range) 4. No severe cardiopulmonary dysfunction or other comorbidities that affect the tolerance of general anesthesia and surgery 5. Women of childbearing age must take appropriate medical contraceptive measures during the study period and within 4 weeks after the end of the trial treatment 6. Patients with good compliance, who voluntarily participate in this clinical study and sign the informed consent form. Exclusion Criteria: 1. Patients with other nasal and paranasal sinus diseases excluding chronic rhinosinusitis (such as nasal tumors, fungal sinusitis, and post-traumatic nasal deformities) 2. Patients with coagulation dysfunction, immunodeficiency, or long-term use of anticoagulant/antiplatelet drugs at the time of visit, and females during menstruation 3. Patients who have taken oral glucocorticoids within 1 month prior to the visit 4. Patients with a history of nasal endoscopic surgery or nasal radiotherapy 5. Pregnant or lactating women, or those with severe systemic diseases (such as uncontrolled hypertension, diabetes, hepatic or renal insufficiency) 6. Patients with incomplete clinical data or missing postoperative follow-up data 7. Any other conditions deemed by the researcher as making the subject unsuitable for participating in the trial 8. Patients with poor treatment compliance
Where this trial is running
Qingdao, Shandong
- Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (RECRUITING)
Study contacts
- Study coordinator: Yan Jiang, MD
- Email: jiangyanoto@qdu.edu.cn
- Phone: +86 13256875886
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chronic Rhinosinusitis With Nasal Polyps