Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-26 @ 1:33 AM
Study NCT ID:
NCT05741333
Status:
RECRUITING
Last Update Posted:
2025-04-17
First Post:
2023-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
In-Office Clinical Study of the Solo+ TTD
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': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2023-02-14', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure Success', 'timeFrame': 'Intra-operative', 'description': 'Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears'}, {'measure': 'Rate of Adverse Events', 'timeFrame': '24 months', 'description': 'Incidence and nature of device- or procedure-related adverse events'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Ear Infection', 'Otitis Media']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.', 'detailedDescription': 'The study will be a multi-site, prospective, treatment-only study to gather safety and effectiveness data on the use of the Solo+ TTD in-office with topical anesthesia in children aged ≥6 months to \\<13 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged ≥6 months to \\<13 years\n* Planned tympanostomy tube insertion\n* Patient is able to commit to the follow-up visits and assessments\n\nExclusion Criteria:\n\n* Anatomy that precludes sufficient visualization of the tympanic membrane\n* Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD\n* Narrow ear canals\n* Congenital or craniofacial abnormalities affecting the ear\n* No baseline audiometry or tympanometry\n* Familial history of insensitivity to anesthetic components\n* Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure'}, 'identificationModule': {'nctId': 'NCT05741333', 'acronym': 'VENTY', 'briefTitle': 'In-Office Clinical Study of the Solo+ TTD', 'organization': {'class': 'INDUSTRY', 'fullName': 'AventaMed DAC'}, 'officialTitle': 'Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device', 'orgStudyIdInfo': {'id': 'CSP003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Solo+ Tympanostomy Tube Device (Solo+ TTD)', 'description': 'The Solo+ TTD is a disposable surgical tool designed to deliver a tympanostomy tube into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure.', 'interventionNames': ['Device: Solo+ Tympanostomy Tube Device (Solo+ TTD)']}], 'interventions': [{'name': 'Solo+ Tympanostomy Tube Device (Solo+ TTD)', 'type': 'DEVICE', 'description': 'The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient.', 'armGroupLabels': ['Solo+ Tympanostomy Tube Device (Solo+ TTD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35010', 'city': 'Alexander City', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nikki Cordes', 'role': 'CONTACT', 'email': 'ncordes@medovationresearch.com'}], 'facility': 'Southern Head & Neck Surgery', 'geoPoint': {'lat': 32.94401, 'lon': -85.95385}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily Weske', 'role': 'CONTACT', 'email': 'eweske@medovationresearch.com'}], 'facility': 'North Alabama ENT', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36801', 'city': 'Opelika', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sierra Macon', 'role': 'CONTACT', 'email': 'smacon@medovationresearch.com'}], 'facility': 'East Alabama ENT', 'geoPoint': {'lat': 32.64541, 'lon': -85.37828}}, {'zip': '95661', 'city': 'Sacramento', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Sacramento ENT', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '40220', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Advanced ENT & Allergy', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '18017', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Specialty Physician Associates', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '29203', 'city': 'Columbia', 'state': 'South Carolina', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'South Carolina ENT', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'centralContacts': [{'name': 'Keith Jansen', '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AventaMed DAC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}