Evaluation of Efficacy and Safety of a Real-time Typing Diagnosis System for Eosinophilic Nasal Polyps Based on High-sensitivity Spectroscopy Technology
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 353
- Locations
- 1
- Primary Endpoint
- The agreement between the results of device-based typing diagnosis and the pathological gold standard
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Patients who have taken oral glucocorticoids within 1 month prior to the visit
- •Patients with a history of nasal endoscopic surgery or nasal radiotherapy
- •Pregnant or lactating women, or those with severe systemic diseases (such as uncontrolled hypertension, diabetes, hepatic or renal insufficiency)
- •Patients with incomplete clinical data or missing postoperative follow-up data
- •Any other conditions deemed by the researcher as making the subject unsuitable for participating in the trial
- •Patients with poor treatment compliance
Outcomes
Primary Outcomes
The agreement between the results of device-based typing diagnosis and the pathological gold standard
Time Frame: 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.
The agreement between the device-based typing diagnosis and the pathological gold standard is assessed by comparing the classification of nasal polyps as eosinophilic or non-eosinophilic using the high-sensitivity spectroscopy system with autofluorescence to the histopathological results from biopsy or surgical sampling. Agreement is measured using the Cohen's kappa coefficient, where a value of 0 indicates no agreement beyond chance, and 1 indicates perfect agreement. The target is a kappa coefficient ≥0.80, indicating substantial agreement. Sensitivity (≥90%) and specificity (≥85%) of the device-based diagnosis are also calculated, with histopathology as the reference standard.
Secondary Outcomes
No secondary outcomes reported