NCT04332575

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

April 3, 2020

Status Verified

April 1, 2020

Enrollment Period

Same day

First QC Date

March 30, 2020

Last Update Submit

April 1, 2020

Conditions

Septal DeformityNasal Obstruction

Keywords

Nasal obstructionSeptal deformitySeptoplastyTnR Nasal Meshpolycaprolactone

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (8)

  • NOSE score change

    1 day

  • Acoustic rhinometry results(volume)

    1 day

  • Acoustic rhinometry results(cross sectional area)

    1 day

  • CT images(cross sectional area)

    1 day

  • CT images(ratio of convex to concave side)

    1 day

  • +3 more secondary outcomes

Eligibility Criteria

Age19 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients between the ages of 19 and 74, who have completed nasal septal deformity surgery using TnR Nasal Mesh.

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 25883105BACKGROUND

  • Kim 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.

    PMID: 21819753BACKGROUND

  • Rimmer 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.

    PMID: 22986938BACKGROUND

  • Boenisch 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.

    PMID: 20083734BACKGROUND

  • Kahveci 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.

    PMID: 21885221BACKGROUND

  • Stewart 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.

    PMID: 15054368BACKGROUND

  • Kim 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.

    PMID: 23094256BACKGROUND

  • Garcia 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.

    PMID: 21537619BACKGROUND

  • Erickson 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.

    PMID: 26754620BACKGROUND

Related Links

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Study Officials

  • Sung-won Kim, professor

    The Catholic University of Korea

    STUDY DIRECTOR

Central Study Contacts

Jeongmin Choi, pm

CONTACT

02-2258-7896Jeongmin.choi@mediex.co.kr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 2, 2020

Study Start

April 1, 2020

Primary Completion

April 1, 2020

Study Completion

November 1, 2020

Last Updated

April 3, 2020

Record last verified: 2020-04