Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT05967169
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-02
First Post:
2023-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EFS of Bioabsorbable Implant for NSD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multi-cohort'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2023-07-13', 'studyFirstSubmitQcDate': '2023-07-21', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of participants with successful implantation as measured through physician's assessment and patient reported outcomes", 'timeFrame': '24 months', 'description': 'Feasibility of implantation and durability of Implant through the healing process'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Nasal Septal Deviation']}, 'referencesModule': {'references': [{'pmid': '40468718', 'type': 'DERIVED', 'citation': 'Davis SE, Davis GE. The Safety and Efficacy of a Bioabsorbable Implant for Correction of Cartilaginous Septal Deviation. Ear Nose Throat J. 2025 Jun 4:1455613251346589. doi: 10.1177/01455613251346589. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Early feasibility study of bioabsorbable implant and delivery device for correction of septal deviation', 'detailedDescription': 'To obtain safety, device performance, patient tolerability and effectiveness outcome data in participants with cartilaginous septal deviations undergoing placement of the Spirair Implant with the Spirair delivery device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Non-calcified, mobile cartilaginous septal deviation.\n* ≥21 years of age.\n* Willing and able to provide informed consent and comply with the study protocol.\n* Seeking treatment for nasal airway obstruction (NAO) due to septal deviation and is willing to undergo a nasal implant procedure.\n* Type I, II, or III septal deviation as defined by 7-Degree Mladina classification scheme\n* NOSE score ≥30 at Screening Visit.\n* Appropriate nasal anatomy to receive the implant(s).\n\nExclusion Criteria:\n\n* Type IV, V, VI or VII septal deviation as defined by 7-Degree Mladina classification scheme (See Table 2) or other non-cartilaginous septum anatomical pathology identified on CT scan suspected by Investigator to be the primary contributor to NAO.\n* Having a concurrent ENT procedure, other than turbinate reduction.\n* Previous septoplasty or rhinoplasty.\n* Has had turbinate reduction or other nasal surgeries within the past six (6) months.\n* Plans to have any surgical or non-surgical treatment of their nasal septum, other than the index procedure, within six (6) months of the procedure.\n* Permanent implant or dilator in the nasal area.\n* Concomitant autoimmune, inflammatory, or infectious skin conditions, unhealed wounds, septal perforation, or mucosal irregularities in the treatment area.\n* Currently has active nasal vestibulitis or folliculitis.\n* History of nasal vasculitis.\n* Current or chronic systemic steroid and/or recreational intra-nasal drug user.\n* Has had a cancerous or pre-cancerous lesion and/or has had radiation exposure in the treatment area or active chemotherapy.\n* Polyps or pathology, other than turbinate hypertrophy, that may be primary contributor to airway obstruction, in the opinion of the investigator.\n* History of a significant bleeding disorder(s) and/or current prescription blood thinner medication that would prevent healing of the treatment area post procedure.\n* Known or suspected allergy to polydioxanone or other absorbable materials.\n* Significant systemic disease such as poorly controlled diabetes or connective tissue disease which, in the investigator's opinion, could pre-dispose the participant to poor wound healing.\n* Current tobacco or tobacco-related product use or history within the past 10 years of heavy smoking (on average, more than half a pack of cigarettes per day).\n* Female participants of childbearing potential who are known or suspected to be pregnant and/or lactating.\n* Any physical condition that, in the Investigator's opinion, would prevent adequate study participation or increase risk.\n* Additionally, for OR cases (Cohorts 1 or 3) any individual who meets the following criteria will be ineligible for enrollment as an OR case\n\n * Is not a candidate for procedures conducted under general anesthesia.\n* Additionally, for in-office cases (Cohort 2) any individual who meets the following criteria will be ineligible for enrollment as an in-office case:\n\n * s not a candidate for procedures conducted under local anesthesia alone."}, 'identificationModule': {'nctId': 'NCT05967169', 'briefTitle': 'EFS of Bioabsorbable Implant for NSD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spirair, Inc'}, 'officialTitle': 'Early Feasibility Study of Bioabsorbable Polydioxanone Implant and Delivery Device for Correction of Cartilaginous Septal Deviation', 'orgStudyIdInfo': {'id': 'CT-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Index Procedure in OR, placement of one implant', 'interventionNames': ['Device: Nasal Septal Strap implantation']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Index Procedure in office or OR, placement of one implant', 'interventionNames': ['Device: Nasal Septal Strap implantation']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Index Procedure in OR, placement of up to two implant', 'interventionNames': ['Device: Nasal Septal Strap implantation']}], 'interventions': [{'name': 'Nasal Septal Strap implantation', 'type': 'DEVICE', 'description': 'Correction of NSD with Nasal Septal Strap implant', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90503', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Breathe Clear Institute', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '18017', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Specialty Physicians', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spirair, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}