Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07125586

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

Led by The Affiliated Hospital of Qingdao University · Updated on 2025-12-30

353

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female subjects aged 18 to 65 years old
  • Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP) by nasal endoscopy, CT, or MRI before surgery
  • Normal blood clotting test results including prothrombin time, activated partial thromboplastin time, and platelet count
  • No severe heart or lung problems or other conditions that would affect tolerance to general anesthesia and surgery
  • Women of childbearing age agree to use effective contraception during the study and for 4 weeks after
  • Good compliance and voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Other nasal or sinus diseases besides chronic rhinosinusitis, such as nasal tumors, fungal sinusitis, or nasal deformities from injury
  • Blood clotting problems, immune system deficiencies, current use of blood thinners or antiplatelet drugs, or menstruating females at the time of visit
  • Use of oral glucocorticoids within 1 month before the visit
  • History of nasal endoscopic surgery or nasal radiotherapy
  • Pregnancy, breastfeeding, or severe systemic diseases like uncontrolled high blood pressure, diabetes, liver or kidney failure
  • Missing clinical data or incomplete follow-up after surgery
  • Any other condition that the researcher believes makes participation unsuitable
  • Poor compliance with treatment or study procedures

AI-Screening

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Trial Site Locations

Total: 1 location

1

Affiliated Hospital of Qingdao University

Qingdao, Shandong, China, 266003

Actively Recruiting

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Research Team

Y

Yan Jiang, MD

CONTACT

S

Shunke Li, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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