Real-time detection of eosinophilic nasal polyps using high-sensitivity spectroscopy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Affiliated Hospital of Qingdao University
  Qingdao, Shandong, China Recruiting

Study contacts

• Study coordinator: Yan Jiang, MD
• Email: jiangyanoto@qdu.edu.cn
• Phone: +86 13256875886

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis with Nasal Polyps

  This study tests whether metabolic and immune markers in nasal tissue and blood differ between people with nasal polyps and those without, to help understand CRSwNP and find potential diagnostic clues.

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• Tezepelumab in real-world CRSwNP: a real-world look at patient outcomes

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• BBT002 in healthy adults and in people with chronic rhinosinusitis with nasal polyps

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  Recruiting at 12 sites Phase 1/2 Bambusa Therapeutics · Beijing, Beijing Municipality and 11 other locations · NCT07436949

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• Joint pulmonologist and ENT consult for asthma with nasal polyps care

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• Understanding how inflammation affects smell in chronic rhinosinusitis

  This study is testing whether a new treatment for inflammation can help improve the sense of smell in people with chronic rhinosinusitis and nasal polyps.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.