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

March 16, 2017 updated by: T&R Biofab Co., Ltd.

A Multi-center, Non-randomized, Open, Single-arm Confirmatory Clinical Study to Evaluate the Safety and Efficacy of Surgical Material for Nasal Septoplasty in Septal Deformity Patients With Nasal Obstruction

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 above symptoms of nasal obstruction and so far, many surgical technique have been studied. All surgical techniques aimed to improve breathing through the nasal cavity by supporting the end of nose using surgical materials such as autologous bone or nonabsorbable material.

In the case of autologous bone transplantation, safety is ensured, but there is a limitation since it causes deficiency of the donor site, and the nasal septum may be altered by a modification of the implanted tissue.

In the case of nonabsorbable materials, there is a high risk of side effects such as hyposmia, septal perforation, and occurrence of boil.

TnR mesh, as a surgical material for nasal septoplasty has a sufficient flexural strength to support the nasal septum and to overcome the force of returning to a deviated state prior to surgery.

Animal tests have shown that TnR mesh well supports the nasal septum after surgery and the surrounding tissue is well fused between the pores without inflammatory responses. Based on above results, a clinical trial was planned to evaluate the efficacy and safety of TnR mesh as a material for nasal septoplasty.

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Kyunggi-do
      • Bucheon, Kyunggi-do, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea
        • Contact:
    • Seocho-gu
      • Seoul City, Seocho-gu, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with septal deformity
To evaluate the safety and efficacy of surgical material for nasal septoplasty in septal deformity patients with nasal obstruction
Procedure: Nasal septoplasty
Type of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NOSE total scores at 12 weeks after the surgery
Time Frame: 12 weeks
The change in NOSE total scores of the 12th week after the surgery
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NOSE total scores
Time Frame: 4 weeks
The change in NOSE total scores 4 weeks after the surgery
4 weeks
NOSE score by topic
Time Frame: 4 and 12 weeks
NOSE score by topic 4, 12 weeks after the surgery
4 and 12 weeks
Acoustic rhinometry results(cross-sectional sum)
Time Frame: 4 and 12 weeks
Changes in bilateral nasal cavity cross sectional sum in acoustic rhinometry results 4, 12 weeks after the surgery
4 and 12 weeks
Acoustic rhinometry results(volume sum)
Time Frame: 4 and 12 weeks
Changes in bilateral nasal cavity volume sum in acoustic rhinometry results 4, 12 weeks after the surgery
4 and 12 weeks
CT images(cross sectional area)
Time Frame: 12 weeks
Changes in nasal cavity cross-sectional area in CT images 12 weeks after the surgery
12 weeks
CT images(ratio of convex to concave side)
Time Frame: 12 weeks
Changes in nasal cavity raio of convex to concave side of cross-sectional area in CT images 12 weeks after the surgery
12 weeks
CT images(nasal septum angle)
Time Frame: 12 weeks
Changes in nasal septum angle in CT images 12 weeks after the surgery
12 weeks
Ratio of improvement regarding symptoms
Time Frame: 12 weeks
Ratio of improvement regarding symptoms 12 weeks after surgery
12 weeks
Level of satisfaction of patients
Time Frame: 12 weeks
Satisfaction score(used visual analogue scale) of subject 12 weeks after surgery
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Deviant-cases
Time Frame: 12 weeks

A follow-up will be performed after the surgery until the end of the clinical trial period. Any newly occurred or worsen symptoms will be recorded.

Preparation content: Deviant-cases name, expression date, disappearance date, severity, gravity, results, a relationship between a medical device, a treatment, a status(remove or not).

All deviant-cases are standardized as System Organ Class (SOC) and Preferred Term (PT) according to Medical Dictionary for regulatory activities (MedDRA). The analysis of deviant-case is based on the Treatment Emergent Adverse Event (TEAE). The percentage and the number of deviant cases and abnormal reactions to the device will be proposed as well as the 95 % of confidence interval of the incidence.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

T&R Biofab Co., Ltd.

Investigators

  • Study Director: Se-Hwan Hwang, professor, The Catholic University of Korea Bucheon St.Mary's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

February 9, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNRBIOFAB-CTS01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nasal Obstruction

Clinical Trials on Nasal septoplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe