Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-29 @ 1:48 PM
Study NCT ID:
NCT05863468
Status:
UNKNOWN
Last Update Posted:
2023-05-18
First Post:
2023-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantification of the Airflow Into Sinuses Before and After ArchSinus Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '4 chronic sinusitis patients will undergo unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation. Baseline and 12-week airflow rate and particle deposition will be analyzed with Computational Modeling Analysis. symptomatic improvement will be analyzed using SNOT-22 and NOSE questioners.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-12-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-15', 'studyFirstSubmitDate': '2023-01-29', 'studyFirstSubmitQcDate': '2023-05-15', 'lastUpdatePostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sinus airflow and particle deposition rate', 'timeFrame': '12 weeks', 'description': 'The primary objective of this study aims to compare the sinonasal airflow rate and particle deposition rate at Baseline and 12 weeks after the ArchSinus stent implantation, based on CFD analysis.'}], 'secondaryOutcomes': [{'measure': 'Symptomatic improvement', 'timeFrame': '12 weeks', 'description': 'The secondary objective of this study is to analyze correlation between an increased sinus airflow and symptomatic improvement, assessed using SNOT-22 and NOSE Questioners, at baseline and at 1, 6 and 12 weeks after the ArchSinus stent removal.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Sinusitis, Ethmoidal']}, 'descriptionModule': {'briefSummary': 'This is a single-center, single-arm, interventional case study designed to compare the sinonasal airflow and symptomatic status of four (4) chronic sinusitis patients, before and after the ArchSinus stent implantation.', 'detailedDescription': 'This is a single-center, single-arm, interventional case study. This case study is designed to compare the sinonasal airflow and symptomatic status of four (4) chronic sinusitis patients who after undergoing primary FESS were seen to have symptomatic lateralization of the middle turbinate and underwent medialization of the middle turbinate accompanied by ArchSinus stent implantation.\n\nPatient eligibility will be confirmed based on the endoscopic examination and SNOT-22 score.\n\nPatient history will be taken, specifically which if any nasal spacer was used after the primary FESS.\n\n4 chronic sinusitis patients that suffer from middle turbinate lateralization and symptomatic deterioration, 3-6 months after primary FESS, that met the inclusion / exclusion criteria, will undergo unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation. The stents will be removed 2-3 weeks after procedure.\n\nCT scan will be performed at baseline and 12 weeks after the ArchSinus stent removal, and 3D sinonasal airways reconstruction of the maxillary, ethmoid, sphenoid \\& frontal sinuses will be performed. Subsequently, airflow and particle deposition will be simulated in each reconstruction, and airflow rate and particle deposition will be quantified for different sinuses.\n\nSymptomatic status will be analyzed at baseline and 1, 6 and 12 weeks after the ArchSinus stent removal using SNOT-22 and NOSE Questioners.\n\nDebridement is disallowed during the ArchSinus implantation time period. Nasal decongestions are disallowed prior to CT scan examination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male/female, 18 year or older\n* Diagnosis of chronic rhinosinusitis defined as symptomatic inflammation of the sinuses of at least 12 consecutive weeks duration despite medical management\n* ≥ 3 months post primary FESS\n* Symptoms of chronic rhinosinusitis defined as ≥ 10 score on SNOT-22\n* Middle turbinate lateralization defined as ˃ 2 score on MT lateralization scale\n\nExclusion Criteria:\n\n* Polyp grade ˃ 4 bilaterally on Lildholdt's scale (1-3)\n* Sinonasal tumors\n* Known allergy to nickel\n* Known polyurethane induced dermatitis\n* History of immune deficiency\n* Cystic fibrosis\n* Pregnant or lactating female\n* Acute sinus inflammation\n* Coagulation disorders"}, 'identificationModule': {'nctId': 'NCT05863468', 'briefTitle': 'Quantification of the Airflow Into Sinuses Before and After ArchSinus Implantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'STS Medical'}, 'officialTitle': 'Quantification of the Airflow Into Sinuses Before and After ArchSinus Implantation', 'orgStudyIdInfo': {'id': '461010P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ArchSinus implantation', 'description': 'Subjects will undergo unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation', 'interventionNames': ['Device: ArchSinus implantation']}], 'interventions': [{'name': 'ArchSinus implantation', 'type': 'DEVICE', 'description': 'Unilateral or bilateral in-office middle turbinate medialization and subsequent ArchSinus implantation', 'armGroupLabels': ['ArchSinus implantation']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'STS Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}