Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-20 @ 9:58 PM
Study NCT ID:
NCT02559050
Status:
COMPLETED
Last Update Posted:
2015-09-24
First Post:
2015-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nasal Reconstruction Using a Customized 3D-printed Nasal Stent for Congenital Arhinia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537438', 'term': 'Arrhinia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2015-08-26', 'studyFirstSubmitQcDate': '2015-09-23', 'lastUpdatePostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nasal cavity diameter', 'timeFrame': '6 months', 'description': 'Change from baseline nasal cavity diameter (measured by CT sagittal section, in millimeters)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Arhinia']}, 'referencesModule': {'references': [{'pmid': '30247752', 'type': 'DERIVED', 'citation': 'Jung JW, Ha DH, Kim BY, Seo BF, Han HH, Kim DH, Rhie JW, Kim SW, Cho DW. Nasal Reconstruction Using a Customized Three-Dimensional-Printed Stent for Congenital Arhinia: Three-Year Follow-up. Laryngoscope. 2019 Mar;129(3):582-585. doi: 10.1002/lary.27335. Epub 2018 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'A 7-year-old arhinia patient receives nasal reconstruction with nasal cavity reconstruction and is aided with the application of a 3D-printed nasal stent to prevent nasal cavity constriction.', 'detailedDescription': 'After reconstruction of a nasal cavity in the maxilla by burring using a navigation system, the patient required a nasal stent to prevent stenosis. However there was no conventional stent available. A 3D-printed silicone nasal stent was custom made for the cavity and inserted.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A 7-year-old male patient with congenital arhinia with no history of previous treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single patient\n* 7-year-old male\n* Congenital arhinia\n* No history of previous treatment\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02559050', 'briefTitle': 'Nasal Reconstruction Using a Customized 3D-printed Nasal Stent for Congenital Arhinia', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'Nasal Reconstruction Using a Customized 3D-printed Nasal Stent for Congenital Arhinia', 'orgStudyIdInfo': {'id': 'SM-AR-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Customized 3D-printed nasal stent', 'type': 'OTHER', 'description': "Silicone stent with unconventional shape, 3D-printed based on patient's computed topographical images, to exactly fit newly made nasal cavity."}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seoul St. Mary's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Pohang University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jong-Won Rhie MD.PhD', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}