Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy (NCT07125586) | Clinical Trial Compass
RecruitingNot Applicable
Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy
China353 participantsStarted 2025-08-26
Plain-language summary
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a common condition causing nasal congestion, discharge, and reduced sense of smell, seriously affecting patients' quality of life. A subtype called eosinophilic CRSwNP (eCRSwNP) is difficult to treat and often recurs after surgery.
Currently, diagnosing this subtype requires tissue samples after surgery, which delays treatment decisions and may lead to unnecessary surgeries. Our research team has developed a new, non-invasive diagnostic system using advanced spectral technology to detect a natural fluorescence marker inside eosinophils (a type of immune cell) in nasal polyps. This system can quickly identify eCRSwNP before surgery by shining a safe light on the nasal tissue and analyzing the fluorescence signals.
This study aims to evaluate how accurate and safe this real-time diagnostic system is in clinical practice. If successful, it will help doctors choose better personalized treatments, reduce unnecessary surgeries, lower recurrence rates, and ultimately improve patients' lives.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male and female subjects aged 18 to 65 years old
✓. Subjects diagnosed with CRSwNP by nasal endoscopy, CT, or MRI preoperatively (in accordance with the diagnostic criteria of EPOS 2020)
✓. Normal coagulation function (prothrombin time \[PT\], activated partial thromboplastin time \[APTT\], and platelet count are within the normal range)
✓. No severe cardiopulmonary dysfunction or other comorbidities that affect the tolerance of general anesthesia and surgery
✓. 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
✓. Patients with good compliance, who voluntarily participate in this clinical study and sign the informed consent form.
Exclusion criteria
✕. Patients with other nasal and paranasal sinus diseases excluding chronic rhinosinusitis (such as nasal tumors, fungal sinusitis, and post-traumatic nasal deformities)
✕. Patients with coagulation dysfunction, immunodeficiency, or long-term use of anticoagulant/antiplatelet drugs at the time of visit, and females during menstruation
What they're measuring
1
The agreement between the results of device-based typing diagnosis and the pathological gold standard
Timeframe: From initial device-based diagnostic testing at the baseline visit (Day 0) to histopathological confirmation of nasal polyp tissue obtained via biopsy or surgery, up to 14 days post-procedure.
Trial details
NCT IDNCT07125586
SponsorThe Affiliated Hospital of Qingdao University