Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-02-28 @ 12:41 AM
Study NCT ID:
NCT03088618
Status:
UNKNOWN
Last Update Posted:
2017-03-23
First Post:
2017-02-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study to Evaluate the Safety and Efficacy of Surgical Material for Nasal Septoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015508', 'term': 'Nasal Obstruction'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000402', 'term': 'Airway Obstruction'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-16', 'studyFirstSubmitDate': '2017-02-09', 'studyFirstSubmitQcDate': '2017-03-16', 'lastUpdatePostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Deviant-cases', 'timeFrame': '12 weeks', 'description': '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.\n\nPreparation content: Deviant-cases name, expression date, disappearance date, severity, gravity, results, a relationship between a medical device, a treatment, a status(remove or not).\n\nAll 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.'}], 'primaryOutcomes': [{'measure': 'NOSE total scores at 12 weeks after the surgery', 'timeFrame': '12 weeks', 'description': 'The change in NOSE total scores of the 12th week after the surgery'}], 'secondaryOutcomes': [{'measure': 'NOSE total scores', 'timeFrame': '4 weeks', 'description': 'The change in NOSE total scores 4 weeks after the surgery'}, {'measure': 'NOSE score by topic', 'timeFrame': '4 and 12 weeks', 'description': 'NOSE score by topic 4, 12 weeks after the surgery'}, {'measure': 'Acoustic rhinometry results(cross-sectional sum)', 'timeFrame': '4 and 12 weeks', 'description': 'Changes in bilateral nasal cavity cross sectional sum in acoustic rhinometry results 4, 12 weeks after the surgery'}, {'measure': 'Acoustic rhinometry results(volume sum)', 'timeFrame': '4 and 12 weeks', 'description': 'Changes in bilateral nasal cavity volume sum in acoustic rhinometry results 4, 12 weeks after the surgery'}, {'measure': 'CT images(cross sectional area)', 'timeFrame': '12 weeks', 'description': 'Changes in nasal cavity cross-sectional area in CT images 12 weeks after the surgery'}, {'measure': 'CT images(ratio of convex to concave side)', 'timeFrame': '12 weeks', 'description': 'Changes in nasal cavity raio of convex to concave side of cross-sectional area in CT images 12 weeks after the surgery'}, {'measure': 'CT images(nasal septum angle)', 'timeFrame': '12 weeks', 'description': 'Changes in nasal septum angle in CT images 12 weeks after the surgery'}, {'measure': 'Ratio of improvement regarding symptoms', 'timeFrame': '12 weeks', 'description': 'Ratio of improvement regarding symptoms 12 weeks after surgery'}, {'measure': 'Level of satisfaction of patients', 'timeFrame': '12 weeks', 'description': 'Satisfaction score(used visual analogue scale) of subject 12 weeks after surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nasal obstruction', 'Septal deformity', 'Septoplasty', 'TnR Mesh', 'polycaprolactone'], 'conditions': ['Septal Deformity', 'Nasal Obstruction']}, 'referencesModule': {'references': [{'pmid': '25883105', 'type': 'BACKGROUND', 'citation': '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': '21819753', 'type': 'BACKGROUND', 'citation': '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': '22986938', 'type': 'BACKGROUND', 'citation': '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': '20083734', 'type': 'BACKGROUND', 'citation': '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': '21885221', 'type': 'BACKGROUND', 'citation': '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': '15054368', 'type': 'BACKGROUND', 'citation': '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': '23094256', 'type': 'BACKGROUND', 'citation': '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': '21537619', 'type': 'BACKGROUND', 'citation': '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': '26754620', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://webnet.oecd.org/hpv/UI/handler.axd?id=2ccdc186-93a9-47cd-b91d-26789738233d', 'label': 'SIDS Initial Assessment Report'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Nasal obstruction is a nasal disease commonly seen in the area of otolaryngology, and major symptoms include nasal congestion, rhinitis, and etc.\n\nNasal 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.\n\nIn 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.\n\nIn the case of nonabsorbable materials, there is a high risk of side effects such as hyposmia, septal perforation, and occurrence of boil.\n\nTnR 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.\n\nAnimal 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with nasal septal deformity who require surgical treatment\n2. Females of childbearing potential must have a negative urine pregnancy test, and must not plan to become pregnant during the course of the study.\n\nExclusion Criteria:\n\n1. Known allergic reaction to medical devices(TnR mesh) of the clinical trial\n2. Pregnancy or lactation\n\n \\- Before screening\n3. History of surgery in nasal or paranasal sinuses before screening\n4. History of radiation treatment at Head and neck\n5. History of having participated in other clinical trial of a drug/ a medical device within three months\n\n \\- Screening point\n6. Patients with untreated nasal bone fraction or trauma of nasal\n7. Patients with surgical site infection caused by nasal bone fraction or trauma\n8. Patients with untreated a perforation of septum, a sinusitis, a nasal cavity polyposis, a nasal cavity sarcoidosis, nasal valve collapse or wegener's granulomatosis\n9. Patients with inflammation in a nasal cavity\n10. Patients with sarcoma or carcinoma in a nasal cavity\n11. Patients with asthma\n12. Patients with untreated palate-facial disfigurements or cleft palate\n13. Patients with systemic inflammatory disease\n14. Patients with sepsis"}, 'identificationModule': {'nctId': 'NCT03088618', 'briefTitle': 'A Clinical Study to Evaluate the Safety and Efficacy of Surgical Material for Nasal Septoplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'T&R Biofab Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TNRBIOFAB-CTS01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with septal deformity', 'description': 'To evaluate the safety and efficacy of surgical material for nasal septoplasty in septal deformity patients with nasal obstruction', 'interventionNames': ['Procedure: Nasal septoplasty']}], 'interventions': [{'name': 'Nasal septoplasty', 'type': 'PROCEDURE', 'description': 'Type of surgery', 'armGroupLabels': ['Patients with septal deformity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Se-Hwan Hwang, professor', 'role': 'CONTACT', 'email': 'yellobird@catholic.ac.kr', 'phone': '032-340-7044'}], 'facility': 'The Catholic University of Korea', 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}, {'city': 'Seoul', 'state': 'Seocho-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung-won Kim, professor', 'role': 'CONTACT', 'email': 'kswent@catholic.ac.kr', 'phone': '02-2258-6216'}, {'name': 'Do-Hyun Kim', 'role': 'CONTACT', 'email': 'dohyuni9292@naver.com', 'phone': '02-2258-6318'}], 'facility': "The Catholic University of Korea, Seoul ST. Mary's hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jiwon Park, Manager', 'role': 'CONTACT', 'email': 'park.jiwon@lskglobal.com', 'phone': '02--2014-9566'}], 'overallOfficials': [{'name': 'Sung-won Kim, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Catholic University of Korea'}, {'name': 'Se-Hwan Hwang, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': "The Catholic University of Korea Bucheon St.Mary's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'T&R Biofab Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}