Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy (NCT07125586) | Clinical Trial Compass
RecruitingNot Applicable
Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy
China353 participantsStarted 2025-08-26
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The agreement between the results of device-based typing diagnosis and the pathological gold standard
Timeframe: 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.
Trial details
NCT IDNCT07125586
SponsorThe Affiliated Hospital of Qingdao University
. 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