NCT07125586 Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy
| NCT ID | NCT07125586 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Affiliated Hospital of Qingdao University |
| Condition | Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 353 participants |
| Start Date | 2025-08-26 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 353 participants in total. It began in 2025-08-26 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07125586 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Rhinosinusitis With Nasal Polyps (CRSwNP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07125586 currently recruiting?
Yes, NCT07125586 is actively recruiting participants. Contact the research team at jiangyanoto@qdu.edu.cn for enrollment information.
Where is the NCT07125586 trial being conducted?
This trial is being conducted at Qingdao, China.
Who is sponsoring the NCT07125586 clinical trial?
NCT07125586 is sponsored by The Affiliated Hospital of Qingdao University. The trial plans to enroll 353 participants.