Septal DeformityNCT04332575
Clinical Extend Study to Evaluate Safety and Effectiveness of TnR Nasal Mesh for Correction of Nasal Septum on Patients
An observational study of Septal Deformity and Nasal Obstruction, run by T&R Biofab Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Septal Deformity, Nasal Obstruction
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2020to Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients between the ages of 19 and 74, who have completed nasal septal deformity surgery using TnR Nasal Mesh.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Extend Study to Evaluate Safety and Effectiveness of TnR Nasal Mesh for Correction of Nasal Septum on Patients Who Need Correction of Nasal Septum That Accompanies With Rhinanchone Symptom
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.
Read the 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 Nasal 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 Nasal 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 long term safety and efficacy of TnR Nasal Mesh as a material for nasal septoplasty.
- Conditions
- Septal Deformity, Nasal Obstruction
- Keywords
- Nasal obstruction, Septal deformity, Septoplasty, TnR Nasal Mesh, polycaprolactone
- Medical subject headings
- Nasal Obstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
Total NOSE score change after surgery compared to before surgery
The descriptive statistics(population, mean, standard deviation, median, minimum, maximun value) are presented for total NOSE score change after surgery compared to before surgery.
All measurement will be completed at the time of each patient's initial visit, 1 day
Total NOSE score of before surgery is based on the results of previous clinical study.
The NOSE(Nasal Obstruction Symptom Evaluation) score is a 5-step scale (0(asymptomatic)-4(very severe) points) of the severity of each symptom over the past month for the 5 symptoms related to nasal obstruction (nasal hyperemia / snagging / difficulty in breathing / sleeping disorder / difficulty breathing during exercise). Then, it is evaluated by interviewing patient. The total score of 20 points is converted to 100 points and recorded.
Measured: 1 day
Secondary outcomes (8)
NOSE score change
NOSE score change for each item after surgery compared to before.
All measurement will be completed at the time of each patient's initial visit, 1 day
The NOSE(Nasal Obstruction Symptom Evaluation) score is a 5-step scale (0(asymptomatic)-4(very severe) points) of the severity of each symptom over the past month for the 5 symptoms related to nasal obstruction (nasal hyperemia / snagging / difficulty in breathing / sleeping disorder / difficulty breathing during exercise). Then, it is evaluated by interviewing the patient. The total score of 20 points is converted to 100 points and recorded.
Measured: 1 day
Acoustic rhinometry results(volume)
Changes after surgery compared to before surgery on bilateral nasal cavity volume in acoustic rhinometry result.
All measurement will be completed at the time of each patient's initial visit, 1 day
Measured: 1 day
Acoustic rhinometry results(cross sectional area)
Changes after surgery compared to before surgery on bilateral nasal cavity cross sectional area in acoustic rhinometry result.
All measurement will be completed at the time of each patient's initial visit, 1 day
Measured: 1 day
CT images(cross sectional area)
Changes after surgery compared to before surgery on bilateral nasal cavity cross sectional area in CT images.
All measurement will be completed at the time of each patient's initial visit, 1 day
Measured: 1 day
CT images(ratio of convex to concave side)
Changes after surgery compared to before surgery on nasal cavity ratio of convex to concave side of cross-sectional area in CT images.
All measurement will be completed at the time of each patient's initial visit, 1 day
Measured: 1 day
CT images(nasal septum angle)
Changes after surgery compared to before surgery on nasal septum angle in CT images.
All measurement will be completed at the time of each patient's initial visit, 1 day
Measured: 1 day
Ratio of improvement of regarding symptoms after surgery
Symptom improvement is defined as the total NOSE score reduced by more than 40 points compared to before surgery or the total NOSE score less than 20 points after surgery.
All measurement will be completed at the time of each patient's initial visit, 1 day
The NOSE(Nasal Obstruction Symptom Evaluation) score is a 5-step scale (0(asymptomatic)-4(very severe) points) of the severity of each symptom over the past month for the 5 symptoms related to nasal obstruction (nasal hyperemia / snagging / difficulty in breathing / sleeping disorder / difficulty breathing during exercise). Then, it is evaluated by interviewing the patient. The total score of 20 points is converted to 100 points and recorded.
Measured: 1 day
Level of satisfaction of patients using VAS
The patient satisfaction is evaluated using VAS(Visual Analogue Scale).
All measurement will be completed at the time of each patient's initial visit, 1 day
VAS(Visual Analogue Scles)Scoring and Interpretation Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study startApr 2020 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Septal DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- T&R Biofab Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung-won Kim, professor, Study director, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332575
- Sponsor's protocol ID
- TRBF-002
- Status last verified
- Apr 2020
- First submitted
- 30 Mar 2020
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Surowitz J, Lee MK, Most SP. Anterior Septal Reconstruction for Treatment of Severe Caudal Septal Deviation: Clinical Severity and Outcomes. Otolaryngol Head Neck Surg. 2015 Jul;153(1):27-33. doi: 10.1177/0194599815582176. Epub 2015 Apr 16.
PubMed 25883105Kim JH, Kim DY, Jang YJ. Outcomes after endonasal septoplasty using caudal septal batten grafting. Am J Rhinol Allergy. 2011 Jul-Aug;25(4):e166-70. doi: 10.2500/ajra.2011.25.3648.
PubMed 21819753Rimmer J, Ferguson LM, Saleh HA. Versatile applications of the polydioxanone plate in rhinoplasty and septal surgery. Arch Facial Plast Surg. 2012 Sep-Oct;14(5):323-30. doi: 10.1001/archfacial.2012.147.
PubMed 22986938Boenisch M, Nolst Trenite GJ. Reconstruction of the nasal septum using polydioxanone plate. Arch Facial Plast Surg. 2010 Jan-Feb;12(1):4-10. doi: 10.1001/archfacial.2009.103.
PubMed 20083734Kahveci OK, Miman MC, Yucel A, Yucedag F, Okur E, Altuntas A. The efficiency of Nose Obstruction Symptom Evaluation (NOSE) scale on patients with nasal septal deviation. Auris Nasus Larynx. 2012 Jun;39(3):275-9. doi: 10.1016/j.anl.2011.08.006. Epub 2011 Aug 31.
PubMed 21885221Stewart MG, Smith TL, Weaver EM, Witsell DL, Yueh B, Hannley MT, Johnson JT. Outcomes after nasal septoplasty: results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) study. Otolaryngol Head Neck Surg. 2004 Mar;130(3):283-90. doi: 10.1016/j.otohns.2003.12.004.
PubMed 15054368Kim JN, Choi HG, Kim SH, Park HJ, Shin DH, Jo DI, Kim CK, Uhm KI. The efficacy of bioabsorbable mesh as an internal splint in primary septoplasty. Arch Plast Surg. 2012 Sep;39(5):561-4. doi: 10.5999/aps.2012.39.5.561. Epub 2012 Sep 12.
PubMed 23094256Garcia LB, Oliveira PW, Vidigal Tde A, Suguri Vde M, Santos Rde P, Gregorio LC. Caudal septoplasty: efficacy of a surgical technique-preliminary report. Braz J Otorhinolaryngol. 2011 Mar-Apr;77(2):178-84. doi: 10.1590/s1808-86942011000200007.
PubMed 21537619Erickson B, Hurowitz R, Jeffery C, Ansari K, El Hakim H, Wright ED, Seikaly H, Greig SR, Cote DW. Acoustic rhinometry and video endoscopic scoring to evaluate postoperative outcomes in endonasal spreader graft surgery with septoplasty and turbinoplasty for nasal valve collapse. J Otolaryngol Head Neck Surg. 2016 Jan 12;45:2. doi: 10.1186/s40463-016-0115-9.
PubMed 26754620
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Extend Study to Evaluate Safety and Effectiveness of TnR Nasal Mesh for Correction of Nasal Septum on Patients Who Need Correction of Nasal Septum That Accompanies With Rhinanchone Symptom
- ClinicalTrials.gov ID
- NCT04332575
- Acronym / sponsor ID
- TRBF-002
- Conditions
- Septal Deformity, Nasal Obstruction
- Keywords
- Nasal obstruction, Septal deformity, Septoplasty, TnR Nasal Mesh, polycaprolactone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- T&R Biofab Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2020 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 Nasal 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 Nasal 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 long term safety and efficacy of TnR Nasal Mesh as a material for nasal septoplasty.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 19 and 74, who have completed nasal septal deformity surgery using TnR Nasal Mesh.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total NOSE score change after surgery compared to before surgery
Time frame: 1 day
The descriptive statistics(population, mean, standard deviation, median, minimum, maximun value) are presented for total NOSE score change after surgery compared to before surgery. All measurement will be completed at the time of each patient's initial visit, 1 day Total NOSE score of before surgery is based on the results of previous clinical study. The NOSE(Nasal Obstruction Symptom Evaluation) score is a 5-step scale (0(asymptomatic)-4(very severe) points) of the severity of each symptom over the past month for the 5 symptoms related to nasal obstruction (nasal hyperemia / snagging / difficulty in breathing / sleeping disorder / difficulty breathing during exercise). Then, it is evaluated by interviewing patient. The total score of 20 points is converted to 100 points and recorded.
8 secondary outcomes
NOSE score change
Time frame: 1 day
Acoustic rhinometry results(volume)
Time frame: 1 day
Acoustic rhinometry results(cross sectional area)
Time frame: 1 day
CT images(cross sectional area)
Time frame: 1 day
CT images(ratio of convex to concave side)
Time frame: 1 day
CT images(nasal septum angle)
Time frame: 1 day
Ratio of improvement of regarding symptoms after surgery
Time frame: 1 day
Level of satisfaction of patients using VAS
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Background: PubMed 25883105Surowitz J, Lee MK, Most SP. Anterior Septal Reconstruction for Treatment of Severe Caudal Septal Deviation: Clinical Severity and Outcomes. Otolaryngol Head Neck Surg. 2015 Jul;153(1):27-33. doi: 10.1177/0194599815582176. Epub 2015 Apr 16.
- Background: PubMed 21819753Kim JH, Kim DY, Jang YJ. Outcomes after endonasal septoplasty using caudal septal batten grafting. Am J Rhinol Allergy. 2011 Jul-Aug;25(4):e166-70. doi: 10.2500/ajra.2011.25.3648.
- Background: PubMed 22986938Rimmer J, Ferguson LM, Saleh HA. Versatile applications of the polydioxanone plate in rhinoplasty and septal surgery. Arch Facial Plast Surg. 2012 Sep-Oct;14(5):323-30. doi: 10.1001/archfacial.2012.147.
- Background: PubMed 20083734Boenisch M, Nolst Trenite GJ. Reconstruction of the nasal septum using polydioxanone plate. Arch Facial Plast Surg. 2010 Jan-Feb;12(1):4-10. doi: 10.1001/archfacial.2009.103.
- Background: PubMed 21885221Kahveci OK, Miman MC, Yucel A, Yucedag F, Okur E, Altuntas A. The efficiency of Nose Obstruction Symptom Evaluation (NOSE) scale on patients with nasal septal deviation. Auris Nasus Larynx. 2012 Jun;39(3):275-9. doi: 10.1016/j.anl.2011.08.006. Epub 2011 Aug 31.
- Background: PubMed 15054368Stewart MG, Smith TL, Weaver EM, Witsell DL, Yueh B, Hannley MT, Johnson JT. Outcomes after nasal septoplasty: results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) study. Otolaryngol Head Neck Surg. 2004 Mar;130(3):283-90. doi: 10.1016/j.otohns.2003.12.004.
- Background: PubMed 23094256Kim JN, Choi HG, Kim SH, Park HJ, Shin DH, Jo DI, Kim CK, Uhm KI. The efficacy of bioabsorbable mesh as an internal splint in primary septoplasty. Arch Plast Surg. 2012 Sep;39(5):561-4. doi: 10.5999/aps.2012.39.5.561. Epub 2012 Sep 12.
- Background: PubMed 21537619Garcia LB, Oliveira PW, Vidigal Tde A, Suguri Vde M, Santos Rde P, Gregorio LC. Caudal septoplasty: efficacy of a surgical technique-preliminary report. Braz J Otorhinolaryngol. 2011 Mar-Apr;77(2):178-84. doi: 10.1590/s1808-86942011000200007.
- Background: PubMed 26754620Erickson B, Hurowitz R, Jeffery C, Ansari K, El Hakim H, Wright ED, Seikaly H, Greig SR, Cote DW. Acoustic rhinometry and video endoscopic scoring to evaluate postoperative outcomes in endonasal spreader graft surgery with septoplasty and turbinoplasty for nasal valve collapse. J Otolaryngol Head Neck Surg. 2016 Jan 12;45:2. doi: 10.1186/s40463-016-0115-9.
- Description SIDS Initial Assessment ReportLink provided by the sponsor.
Related trials for Septal Deformity
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Recruiting
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Patent Foramen Ovale, Ischemic Stroke
RecruitingPhase 1
Beta-blocker Administration for Cardiomyocyte Division
Tetralogy of Fallot, Double Outlet Right Ventricle
Active, not recruiting
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Stroke, Patent Foramen Ovale
Active, not recruitingObservational study
Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up
Atrial Septal Defect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-won Kim, professor study director
The Catholic University of Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Septal Deformity and Nasal Obstruction, run by T&R Biofab Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeongmin Choi, pm (02-2258-7896, Jeongmin.choi@mediex.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total NOSE score change after surgery compared to before surgery (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04332575, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.