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Recruiting NCT07125586

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

No phase Interventional Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-Sensitivity Spectroscopy with Autofluorescence for eCRSwNP Diagnosis.
Who it may be relevant to
Registry conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Diagnostic test 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,

Primary outcome measures

  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Affiliated Hospital of Qingdao University — Qingdao

Identifiers

NCT: NCT07125586 · QYFYEC2025-73 · MR-37-25-054863

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗