Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy

NCT ID: NCT07125586

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 353 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-26
• Study Completion Date: 2028-06-01

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Evaluation of Eosinophilic CRSwNP Diagnosis Using High-Sensitivity Spectroscopy and Autofluorescence

Patients with CRSwNP (per EPOS2020 criteria) undergo non-invasive testing using a high-sensitivity spectroscopy system with autofluorescence to detect eosinophilic CRSwNP. A probe irradiates nasal polyps, capturing FAD autofluorescence signals (445nm excitation, \~525nm emission) for real-time classification. Tissue is obtained via biopsy or surgery for histopathological confirmation. Safety is assessed by monitoring mucosal irritation, swelling, or bleeding within 24 hours, with pain recorded via VAS (0-10). The study evaluates diagnostic accuracy (sensitivity ≥90%, specificity ≥85%) and safety (adverse event rate ≤3%).

Group Type: EXPERIMENTAL

High-Sensitivity Spectroscopy with Autofluorescence for eCRSwNP Diagnosis

Intervention Type: DIAGNOSTIC_TEST

This intervention employs a non-invasive diagnostic procedure using a high-sensitivity spectroscopy system with autofluorescence to identify eosinophilic chronic rhinosinusitis with nasal polyps (eCRSwNP). A specialized thin probe, guided by an endoscopic light source, contacts nasal polyp tissue to emit a proprietary wavelength laser light, exciting fluorescent substances (primarily flavin adenine dinucleotide, FAD). The probe captures autofluorescence signals at a specific emission wavelength, and signal intensity analysis distinguishes eosinophilic from non-eosinophilic polyps in real-time. Unlike invasive histopathological diagnosis via biopsy or surgery, this method enables rapid preoperative typing. Conducted once at the initial visit, results are validated against post-biopsy/surgical histopathology (gold standard) to assess diagnostic accuracy (sensitivity ≥90%, specificity ≥85%). Safety is monitored for adverse events like mucosal irritation or bleeding within 24 hours.

Interventions

High-Sensitivity Spectroscopy with Autofluorescence for eCRSwNP Diagnosis

This intervention employs a non-invasive diagnostic procedure using a high-sensitivity spectroscopy system with autofluorescence to identify eosinophilic chronic rhinosinusitis with nasal polyps (eCRSwNP). A specialized thin probe, guided by an endoscopic light source, contacts nasal polyp tissue to emit a proprietary wavelength laser light, exciting fluorescent substances (primarily flavin adenine dinucleotide, FAD). The probe captures autofluorescence signals at a specific emission wavelength, and signal intensity analysis distinguishes eosinophilic from non-eosinophilic polyps in real-time. Unlike invasive histopathological diagnosis via biopsy or surgery, this method enables rapid preoperative typing. Conducted once at the initial visit, results are validated against post-biopsy/surgical histopathology (gold standard) to assess diagnostic accuracy (sensitivity ≥90%, specificity ≥85%). Safety is monitored for adverse events like mucosal irritation or bleeding within 24 hours.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Jiang, MD

Role: CONTACT

Phone: +86 13256875886

Email: jiangyanoto@qdu.edu.cn

Shunke Li, MD

Role: CONTACT

Phone: +86 18653394973

Email: lishunkeent@126.com

Facility Contacts

顺科 李

Role: primary

Other Identifiers

MR-37-25-054863

Identifier Type: OTHER

Identifier Source: secondary_id

QYFYEC2025-73

Identifier Type: -

Identifier Source: org_study_id