Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT05049434
Eligibility Criteria:
Inclusion Criteria:
1. Patients at the age of between 19 and 69
2. Patients scheduled for surgery with chronic or relapsed sinusitis not responding to drug therapy (Verification to be made based on past clinical history, physical examination and radiography)
3. Patients with the discrepancy of Lund-MacKay CT scan scores on bilateral sinusitis less than 3
4. Patients who signed written consent after listening to the objective, method and effects of clinical trial
5. Patients available during the period of clinical trial
Exclusion Criteria:
1. Patients with sinusitis on only one nasal cavity
2. Patients with massive sinonasal polyposis
3. Patients with one or both middle turbinate removed, in addition to a history of endoscopic surgery or polyp operation
4. Patients with ongoing drug administration for asthma
5. Patients with immune disorders which may potentially hinder healing of the wounds including acquired immunodeficiency syndrome, cystofibroma, immotile cilia syndrome, neutropenia and immune globulin deficiency
6. Patients with immunosuppression or autoimmune disease
7. Patients with hypersensitivity reaction to Poloxamer and Hyaluronic acid
8. Patients who had surgery to treat extrasinus complication from rhinosinusitis
9. Patients with history of endoscopic sinus surgery for other than chronic or relapsed sinusitis, including cerebrospinal fluid (CSF) leak correction, orbital decompression and optic nerve decompression
10. Patients with significant liver or kidney diseases
11. Patients with setting agent administered or with hemostatic or lymph fluid disorders
12. Patients administered with oral or parenteral drugs for hypoglycemia
13. Patients with significant systematic disease
14. Patients with malignant tumor
15. Patients with infectious disease or suspected of potential problems during the course of healing surgical site (healing disorder)
16. Those who are pregnant or lactiferous
17. Women of childbearing age with plan for pregnancy during the clinical trial period
18. Those who participated in other clinical trials 30 days prior to the participation in this trial
19. In addition to the above, those who are subject to clinical findings where principal investigator or sub-investigator deem inadequate for this clinical trial based on medical judgment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
69 Years
Study:
NCT05049434
Study Brief:
Protocol Section:
NCT05049434