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Evaluation of Efficacy and Safety of a Real-time Typing Diagnosis System for Eosinophilic Nasal Polyps Based on High-sensitivity Spectroscopy Technology

Evaluation of Efficacy and Safety of a Real-time Typing Diagnosis System for Eosinophilic Nasal Polyps Based on High-sensitivity Spectroscopy Technology

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107384
Enrollment
Unknown
Registered
2025-08-11
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

eosinophilic chronic rhinosinusitis with nasal polyps

Interventions

Gold Standard:The gold standard for confirming the diagnosis of eosinophilic chronic sinusitis with nasal polyps is to obtain tissue by biopsy and then confirm the classification by pathological secti
Index test:Real-time Typing Diagnosis System for Eosinophilic Nasal Polyps Based on High-sensitivity Spectroscopy Technology and Autofluorescence Recognition Technology

Sponsors

The Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male and female subjects aged 18-65 years; 2. Subjects were diagnosed with CRSwNP by nasal endoscopy, CT or MRI before surgery (meeting EPOS 2020 diagnostic criteria); 3. Normal coagulation function (PT, APTT, platelet count within normal range); 4. No severe cardiopulmonary dysfunction or other comorbidities affecting general anesthesia and surgical tolerance; 5. Women of childbearing age must take adequate medical contraception during the study period and within 4 weeks after the end of trial treatment; 6. Patients have good compliance, voluntarily participate in this clinical study and sign the informed consent form.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
The agreement between the results of device-based typing diagnosis and the pathological gold standard;

Secondary

MeasureTime frame
Incidence rate of operation-related adverse events associated with spectral equipment;

Countries

China

Contacts

Public ContactYan Jiang

The Affiliated Hospital of Qingdao University

jiangyanoto@qdu.edu.cn+86 532 82915920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026