Septal DeformityNCT03088618
A Clinical Study to Evaluate the Safety and Efficacy of Surgical Material for Nasal Septoplasty
A study testing Nasal septoplasty in people with Septal Deformity and Nasal Obstruction, run by T&R Biofab Co., Ltd. at 2 sites in South Korea.
Trial 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. 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
- What is being tested?
- Nasal septoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Aug 2016to Sep 2017
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- Known allergic reaction to medical devices(TnR mesh) of the clinical trial
- 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
Show all 16Show fewer
- 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 untreated a perforation of septum, a sinusitis, a nasal cavity polyposis, a nasal cavity sarcoidosis, nasal valve collapse or wegener's granulomatosis
- Patients with inflammation in a nasal cavity
- Patients with sarcoma or carcinoma in a nasal cavity
- Patients with asthma
- Patients with untreated palate-facial disfigurements or cleft palate
- Patients with systemic inflammatory disease
- Patients with sepsis
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
The Catholic University of Korea
Bucheon-si, Gyeonggi-do
Se-Hwan Hwang, professor, 032-340-7044, yellobird@catholic.ac.kr
- Recruiting
The Catholic University of Korea, Seoul ST. Mary's hospital
Seoul, Seocho-gu
Sung-won Kim, professor, 02-2258-6216, kswent@catholic.ac.kr
Do-Hyun Kim, 02-2258-6318, dohyuni9292@naver.com
About this study
Official title: 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.
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 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.
- Conditions
- Septal Deformity, Nasal Obstruction
- Being tested
- Nasal septoplasty
- Keywords
- Nasal obstruction, Septal deformity, Septoplasty, TnR Mesh, polycaprolactone
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal septoplastyProcedure or surgery
Type of surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients with septal deformity | Experimental | To evaluate the safety and efficacy of surgical material for nasal septoplasty in septal deformity patients with nasal obstruction Receives: Procedure: Nasal septoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
NOSE total scores at 12 weeks after the surgery
The change in NOSE total scores of the 12th week after the surgery
Measured: 12 weeks
Secondary outcomes (9)
NOSE total scores
The change in NOSE total scores 4 weeks after the surgery
Measured: 4 weeks
NOSE score by topic
NOSE score by topic 4, 12 weeks after the surgery
Measured: 4 and 12 weeks
Acoustic rhinometry results(cross-sectional sum)
Changes in bilateral nasal cavity cross sectional sum in acoustic rhinometry results 4, 12 weeks after the surgery
Measured: 4 and 12 weeks
Acoustic rhinometry results(volume sum)
Changes in bilateral nasal cavity volume sum in acoustic rhinometry results 4, 12 weeks after the surgery
Measured: 4 and 12 weeks
CT images(cross sectional area)
Changes in nasal cavity cross-sectional area in CT images 12 weeks after the surgery
Measured: 12 weeks
CT images(ratio of convex to concave side)
Changes in nasal cavity raio of convex to concave side of cross-sectional area in CT images 12 weeks after the surgery
Measured: 12 weeks
CT images(nasal septum angle)
Changes in nasal septum angle in CT images 12 weeks after the surgery
Measured: 12 weeks
Ratio of improvement regarding symptoms
Ratio of improvement regarding symptoms 12 weeks after surgery
Measured: 12 weeks
Level of satisfaction of patients
Satisfaction score(used visual analogue scale) of subject 12 weeks after surgery
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study startAug 2016
- Primary completionJul 2017 (estimated)
- Study completionSep 2017 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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 KoreaSe-Hwan Hwang, professor, Study director, The Catholic University of Korea Bucheon St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088618
- Sponsor's protocol ID
- TNRBIOFAB-CTS01
- Status last verified
- Mar 2017
- First submitted
- 9 Feb 2017
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03088618
- Acronym / sponsor ID
- TNRBIOFAB-CTS01
- Conditions
- Septal Deformity, Nasal Obstruction
- Keywords
- Nasal obstruction, Septal deformity, Septoplasty, TnR Mesh, polycaprolactone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- T&R Biofab Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 23 Mar 2017 (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 clinical trial is to evaluate safety and efficacy of TnR mesh for patients who need nasal septoplasty for septal deformity with nasal obstruction.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with septal deformity | Experimental | Procedure: Nasal septoplastyTo evaluate the safety and efficacy of surgical material for nasal septoplasty in septal deformity patients with nasal obstruction |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal septoplastyType of surgery | Procedure or surgery | Patients with septal deformity |
Primary outcome
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
9 secondary outcomes
NOSE total scores
Time frame: 4 weeks
NOSE score by topic
Time frame: 4 and 12 weeks
Acoustic rhinometry results(cross-sectional sum)
Time frame: 4 and 12 weeks
Acoustic rhinometry results(volume sum)
Time frame: 4 and 12 weeks
CT images(cross sectional area)
Time frame: 12 weeks
CT images(ratio of convex to concave side)
Time frame: 12 weeks
CT images(nasal septum angle)
Time frame: 12 weeks
Ratio of improvement regarding symptoms
Time frame: 12 weeks
Level of satisfaction of patients
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- 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.
- SIDS Initial Assessment ReportLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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
Se-Hwan Hwang, professor study director
The Catholic University of Korea Bucheon St.Mary's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal septoplasty in people with Septal Deformity and Nasal Obstruction, run by T&R Biofab Co., Ltd. at 2 sites in South Korea.
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 2 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 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jiwon Park, Manager (02--2014-9566, park.jiwon@lskglobal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NOSE total scores at 12 weeks after the surgery (time frame: 12 weeks). 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 NCT03088618, 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 23 Mar 2017.