Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-02-10 @ 11:13 PM
Study NCT ID:
NCT03978195
Status:
UNKNOWN
Last Update Posted:
2019-06-07
First Post:
2019-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Non-invasive Device to Remove Fluid From the Middle Ear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010034', 'term': 'Otitis Media with Effusion'}], 'ancestors': [{'id': 'D010033', 'term': 'Otitis Media'}, {'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008876', 'term': 'Middle Ear Ventilation'}], 'ancestors': [{'id': 'D010030', 'term': 'Ostomy'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013506', 'term': 'Otologic Surgical Procedures'}, {'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-05', 'studyFirstSubmitDate': '2019-06-03', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Middle ear values of Tympanometry', 'timeFrame': '10 weeks', 'description': 'Values will be compared to baseline values of Tympanometry'}, {'measure': 'Middle ear ventilation evaluated by otoscopy', 'timeFrame': '10 weeks', 'description': 'Otoscopy evaluation of ear ventilation will be compared to baseline values'}], 'secondaryOutcomes': [{'measure': 'Auditory test', 'timeFrame': '10 weeks', 'description': 'Values will be compared to baseline values of Auditory test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Otitis Media With Effusion']}, 'descriptionModule': {'briefSummary': "A feasibility study for evaluating efficacy and satisfaction is treated using a non-invasive device for middle ear ventilation.\n\nThe study is designed to test the device's effectiveness by encouraging the evacuation of fluid from the middle ear, aid in hearing improvement, pain relief and assessment of patient satisfaction with the use of the device."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed with ear fluids (OME) according to a doctor's examination for at least 4-6 weeks. There is a progressive hearing impairment and a matching tympanum.\n* In principle, these children (with OME and hearing impairment) meet the criteria and candidates for the analysis of inserting tubes of incontinence (buttons).\n\nExclusion Criteria:\n\n* First encounter: acute ear infection or Proper Otoscopy\n* Second session: First review: Otoscopy / Timpneometry / Hearing test.\n* Parallel treatment: acupuncture - tubes insertion - discontinuation of follow-up - cessation of the experiment initiated by parents"}, 'identificationModule': {'nctId': 'NCT03978195', 'briefTitle': 'A Non-invasive Device to Remove Fluid From the Middle Ear', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuinvent Innovations Ltd.'}, 'officialTitle': 'EMD - A Non-invasive Device for Ventilating the Middle Ear Feasibility Study to Evaluate Efficiency and User Satisfaction', 'orgStudyIdInfo': {'id': '0275-18-MMC (CLEAR OM R1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'interventionNames': ['Device: Non-invasive device for middle ear ventilation']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Non-invasive device for middle ear ventilation', 'type': 'DEVICE', 'description': 'Daily use of the device', 'armGroupLabels': ['Treatment']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuinvent Innovations Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}