NCT03088618

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

August 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

February 9, 2017

Last Update Submit

March 16, 2017

Conditions

Septal DeformityNasal Obstruction

Keywords

Nasal obstructionSeptal deformitySeptoplastyTnR Meshpolycaprolactone

Outcome Measures

Primary Outcomes (1)

  • NOSE total scores at 12 weeks after the surgery

    The change in NOSE total scores of the 12th week after the surgery

    12 weeks

Secondary Outcomes (9)

  • NOSE total scores

    4 weeks

  • NOSE score by topic

    4 and 12 weeks

  • Acoustic rhinometry results(cross-sectional sum)

    4 and 12 weeks

  • Acoustic rhinometry results(volume sum)

    4 and 12 weeks

  • CT images(cross sectional area)

    12 weeks

  • +4 more secondary outcomes

Other Outcomes (1)

  • Deviant-cases

    12 weeks

Study Arms (1)

Patients with septal deformity

EXPERIMENTAL

To evaluate the safety and efficacy of surgical material for nasal septoplasty in septal deformity patients with nasal obstruction

Procedure: Nasal septoplasty

Interventions

Nasal septoplastyPROCEDURE

Type of surgery

Patients with septal deformity

Eligibility Criteria

Age19 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • \- 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Catholic University of Korea

Bucheon-si, Gyeonggi-do, South Korea

RECRUITING

The Catholic University of Korea, Seoul ST. Mary's hospital

Seoul, Seocho-gu, South Korea

RECRUITING

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

  • Se-Hwan Hwang, professor

    The Catholic University of Korea Bucheon St.Mary's Hospital

    STUDY DIRECTOR

Central Study Contacts

Jiwon Park, Manager

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2017

First Posted

March 23, 2017

Study Start

August 1, 2016

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

March 23, 2017

Record last verified: 2017-03

Locations

KR(2)