Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Affiliated Hospital of Qingdao University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Patients who have taken oral glucocorticoids within 1 month prior to the visit
Patients with a history of nasal endoscopic surgery or nasal radiotherapy
Trial design
Treatments tested in this trial
- High-Sensitivity Spectroscopy with Autofluorescence for eCRSwNP Diagnosis
Treatment groups
353 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov