Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT07027267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-18
First Post:
2025-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of TurbAlign™ for Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery
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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2025-06-10', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Miller Synechia Score', 'timeFrame': '8 Weeks', 'description': 'Rate of lateral synechia formation resulting in occlusion of the middle meatus at each turbinate (Miller Synechia Score of 2 or 3) observed at 8 weeks.'}], 'secondaryOutcomes': [{'measure': 'Middle Turbinate Position Grade', 'timeFrame': '4 and 8 weeks', 'description': 'Rate of avoidance of the middle turbinate lateralization at 4 and 8 weeks using Middle Turbinate Position Grade'}, {'measure': 'Miller Synechia Score', 'timeFrame': '4 weeks', 'description': 'Rate of lateral synechia formation resulting gin occlusion of the middle meatus at each turbinate (Miller Synechia Score of 2 or 3) observed at 4 weeks'}, {'measure': 'Inflammation assessment', 'timeFrame': '8 weeks', 'description': 'Inflammation assessment of the gross tissue appearance at implantation site is assessed via live endoscopic video and graded I: None, II: Mild, III: Moderate, IV: Severe by investigator at 8 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Sinus surgery', 'FESS', 'middle turbinate'], 'conditions': ['Sinus Endoscopic Surgery', 'Turbinate']}, 'descriptionModule': {'briefSummary': 'A study of a bioabsorbable implant to separate the middle turbinate from the lateral nasal wall associated with nasal/sinus surgery', 'detailedDescription': 'To evaluate the safety and effectiveness of the Spirair implant as a primary treatment to achieve medialization of the middle turbinate after functional endoscopic sinus surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 to ≤ 70 years of age at time of consent\n* Subject scheduled to undergo bilateral endoscopic sinus surgery\n* Able to speak, read and understand English\n* Willing and able to provide informed consent and comply with the study protocol\n\nExclusion Criteria:\n\n* History of removal of one or both middle turbinates\n* Presence of significant concha bullosa, which requires surgical excision\n* Presence of non-viable tissue at the implantation site\n* Active infection at the implantation site\n* Chronic nasal decongestant use (i.e. Afrin, etc)\n* Recreational intra-nasal drug use within 12 months of enrollment\n* Documented evidence of a history (e.g., liver testing) of drug/alcohol abuse within 12 months of enrollment\n* Hypersensitivity to any investigational device materials including known or suspected allergy to poly(dioxanone) (PDO) or other bioabsorbable materials'}, 'identificationModule': {'nctId': 'NCT07027267', 'acronym': 'Gaia', 'briefTitle': 'Safety and Effectiveness of TurbAlign™ for Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Spirair, Inc'}, 'officialTitle': 'A Prospective, Multi-Center, Open-Label Study to Evaluate the Safety and Effectiveness of TurbAlign™ to Achieve Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery (FESS) (GAIA)', 'orgStudyIdInfo': {'id': 'CT-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-label', 'description': 'Treatment with the Spirair device as a treatment for medialization of the middle turbinates', 'interventionNames': ['Device: Implantation of Spirair device into the middle turbinates', 'Device: TurbAlign']}], 'interventions': [{'name': 'Implantation of Spirair device into the middle turbinates', 'type': 'DEVICE', 'otherNames': ['TurbAlign'], 'description': 'The Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery.', 'armGroupLabels': ['Open-label']}, {'name': 'TurbAlign', 'type': 'DEVICE', 'description': 'The Spirair implant is designed to separate the middle turbinate from the lateral nasal wall during the healing phase associated with nasal/sinus surgery', 'armGroupLabels': ['Open-label']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60005', 'city': 'Arlington Heights', 'state': 'Illinois', 'country': 'United States', 'contacts': [{'name': 'Henry Mantakul', 'role': 'CONTACT', 'email': 'hmantakul@nch.org', 'phone': '847-618-4358'}, {'name': 'Sammy Khalili, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwest Community Hospital', 'geoPoint': {'lat': 42.08836, 'lon': -87.98063}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'contacts': [{'name': 'Mahendra Shah, MD', 'role': 'CONTACT', 'email': 'mahendrakumar_shah@rush.edu', 'phone': '312-942-9967'}, {'name': 'Sukhpreet (Pete) Batra, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70072', 'city': 'Marrero', 'state': 'Louisiana', 'country': 'United States', 'contacts': [{'name': 'Blaire Willis', 'role': 'CONTACT', 'email': 'bwillis@prolerity.com', 'phone': '5049348424'}, {'name': 'Adil Fatakia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tandem Clinical Research', 'geoPoint': {'lat': 29.89937, 'lon': -90.10035}}, {'zip': '71130', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'contacts': [{'name': 'Teresa Leeth', 'role': 'CONTACT', 'email': 'teresa.leeth@lsuhs.edu', 'phone': '318-675-7298'}, {'name': 'Tracy Norwood', 'role': 'CONTACT', 'email': 'tracy.norwood@lsuhs.edu'}, {'name': 'Michael Yim, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'LSU Health Science Center', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Sebastian Guadarrama-Sistos Vazquez, MD', 'role': 'CONTACT', 'email': 'sguadarrama@houstonmethodist.org', 'phone': '346-356-3640'}, {'name': 'Mas Takashima, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Omar Ahmed, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Houston Methodist ENT Specialists', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Margo Snyder', 'role': 'CONTACT', 'email': 'margo@spirair.com', 'phone': '2069482544'}, {'name': 'Laura Ino', 'role': 'CONTACT', 'email': 'lino@spirair.com', 'phone': '4083757448'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spirair, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}