UnknownNot Applicable

A Clinical Study to Evaluate the Safety and Efficacy of Surgical Material for Nasal Septoplasty

South Korea22 participantsStarted 2016-08

Plain-language summary

The purpose of this clinical trial is to evaluate safety and efficacy of TnR mesh for patients who need nasal septoplasty for septal deformity with nasal obstruction.

Who can participate

Age range19 Years – 74 Years

SexALL

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Inclusion criteria

✓. Patients with nasal septal deformity who require surgical treatment
✓. 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

✕. Known allergic reaction to medical devices(TnR mesh) of the clinical trial
✕. Pregnancy or lactation
✕. 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
✕. Patients with untreated nasal bone fraction or trauma of nasal
✕. Patients with surgical site infection caused by nasal bone fraction or trauma
✕. Patients with untreated a perforation of septum, a sinusitis, a nasal cavity polyposis, a nasal cavity sarcoidosis, nasal valve collapse or wegener's granulomatosis

What they're measuring

NOSE total scores at 12 weeks after the surgery

Timeframe: 12 weeks

Trial details

NCT IDNCT03088618

SponsorT&R Biofab Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-07

Contact for this trial

Jiwon Park, Manager

02--2014-9566 park.jiwon@lskglobal.com

View on ClinicalTrials.gov More Septal Deformity trials