Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-03-02 @ 6:23 PM
Study NCT ID:
NCT03722160
Status:
UNKNOWN
Last Update Posted:
2019-10-28
First Post:
2018-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of the Solo Tympanostomy Tube Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'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': 27}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-25', 'studyFirstSubmitDate': '2018-10-25', 'studyFirstSubmitQcDate': '2018-10-25', 'lastUpdatePostDateStruct': {'date': '2019-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful delivery of the tympanostomy tube by the Solo Tympanostomy Tube Device', 'timeFrame': 'Intra-operative', 'description': 'The number of ears in which the Solo Tympanostomy Tube Device tube is placed'}, {'measure': 'Rate of Adverse Events', 'timeFrame': 'Intra-operative, 2-6 weeks post-operative', 'description': 'The number and type of Adverse Events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ear Infection', 'Otitis Media']}, 'descriptionModule': {'briefSummary': 'The objective of this study is post-approval evaluation of the safety and performance of the Solo Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure', 'detailedDescription': 'The study will be a multi-site, prospective, treatment-only study of the Solo Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Listed for bilateral tympanostomy tube insertion\n\nExclusion Criteria:\n\n* Anatomy that precludes sufficient visualisation of both the left and right eardrum\n* Narrow ear canals\n* Anatomy that precludes safe access to both the left and right eardrum\n* Membrane \\>25% sclerosis\n* Congenital or craniofacial abnormalities\n* No available baseline audiometry and tympanometry'}, 'identificationModule': {'nctId': 'NCT03722160', 'briefTitle': 'Clinical Study of the Solo Tympanostomy Tube Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'AventaMed DAC'}, 'officialTitle': 'Clinical Study of the Solo Tympanostomy Tube Device', 'orgStudyIdInfo': {'id': 'CSP001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Solo Tympanostomy Tube Device', 'description': 'The Solo Tympanostomy Tube Device is a disposable surgical tool designed to deliver a tympanostomy tube (grommet) into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure', 'interventionNames': ['Device: Solo TympanostomyTube Device']}], 'interventions': [{'name': 'Solo TympanostomyTube Device', 'type': 'DEVICE', 'description': 'The Solo Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.', 'armGroupLabels': ['Solo Tympanostomy Tube Device']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trieste', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Domenico Leonardo Grasso', 'role': 'CONTACT'}], 'facility': 'IRCCS Burlo-Garofolo', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'city': 'Derby', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Royal Derby Hospital', 'geoPoint': {'lat': 52.92277, 'lon': -1.47663}}, {'city': 'Nottingham', 'status': 'COMPLETED', 'country': 'United Kingdom', 'facility': "Queen's Medical Centre", 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'centralContacts': [{'name': "Olive O'Driscoll", 'role': 'CONTACT', 'email': 'clinical@aventamed.com', 'phone': '+353 21 492 8980'}], 'overallOfficials': [{'name': 'Matija Daniel', 'role': 'STUDY_CHAIR', 'affiliation': "Queen's Medical Center"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make IPD available to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AventaMed DAC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}