Status:
UNKNOWN
Clinical Extend Study to Evaluate Safety and Effectiveness of TnR Nasal Mesh for Correction of Nasal Septum on Patients
Lead Sponsor:
T&R Biofab Co., Ltd.
Conditions:
Septal Deformity
Nasal Obstruction
Eligibility:
All Genders
19-74 years
Brief Summary
The purpose of this observation study is to evaluate long term safety and efficacy at 2\~3 years after surgery on patients who have completed nasal septal deformity surgery using TnR Nasal Mesh.
Detailed Description
Nasal obstruction is a nasal disease commonly seen in the area of otolaryngology, and major symptoms include nasal congestion, rhinitis, and etc. Nasal septoplasty is a surgery performed to improve a...
Eligibility Criteria
Inclusion
- Patients who have completed nasal septal deformity surgery using TnR Nasal Mesh.
- Females of childbearing potential must have a negative urine pregnancy test, and must not plan to become pregnant during the course of the study.
- A person who voluntarily signed a consent form after hearing and understanding the description of this clinical study.
Exclusion
- Pregnancy or lactation
- Before screening
- History of surgery in nasal or paranasal sinuses before screening
- History of radiation treatment at Head and neck
- History of having participated in other clinical trial of a drug/ a medical device within three months
- Screening point
- Patients with untreated nasal bone fraction or trauma of nasal
- Patients with surgical site infection caused by nasal bone fraction or trauma
- Patients with inflammation in a nasal cavity
- Patients with asthma
- Patients with untreated a perforation of septum, a sinusitis, a nasal cavity polyposis, a nasal cavity sarcoidosis, nasal valve collapse or wegener's granulomatosis
- Patients with sarcoma or carcinoma in a nasal cavity
- Patients with untreated palate-facial disfigurements or cleft palate
- Patients with sepsis
- Patients with systemic inflammatory disease
- Patients who are unsuitable for clinical sturdy determined by the researcher.
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04332575
Start Date
April 1 2020
End Date
November 1 2020
Last Update
April 3 2020
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