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 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT03088618
Eligibility Criteria:
Inclusion Criteria:
1. Patients with nasal septal deformity who require surgical treatment
2. Females of childbearing potential must have a negative urine pregnancy test, and must not plan to become pregnant during the course of the study.
Exclusion Criteria:
1. Known allergic reaction to medical devices(TnR mesh) of the clinical trial
2. Pregnancy or lactation
\- Before screening
3. History of surgery in nasal or paranasal sinuses before screening
4. History of radiation treatment at Head and neck
5. History of having participated in other clinical trial of a drug/ a medical device within three months
\- Screening point
6. Patients with untreated nasal bone fraction or trauma of nasal
7. Patients with surgical site infection caused by nasal bone fraction or trauma
8. Patients with untreated a perforation of septum, a sinusitis, a nasal cavity polyposis, a nasal cavity sarcoidosis, nasal valve collapse or wegener's granulomatosis
9. Patients with inflammation in a nasal cavity
10. Patients with sarcoma or carcinoma in a nasal cavity
11. Patients with asthma
12. Patients with untreated palate-facial disfigurements or cleft palate
13. Patients with systemic inflammatory disease
14. Patients with sepsis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
74 Years
Study:
NCT03088618
Study Brief:
Protocol Section:
NCT03088618