A Non-invasive Device to Remove Fluid From the Middle Ear
NCT ID: NCT03978195
Last Updated: 2019-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2019-07-01
2021-11-01
Brief Summary
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The 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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment
Non-invasive device for middle ear ventilation
Daily use of the device
Control
No interventions assigned to this group
Interventions
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Non-invasive device for middle ear ventilation
Daily use of the device
Eligibility Criteria
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Inclusion Criteria
* In principle, these children (with OME and hearing impairment) meet the criteria and candidates for the analysis of inserting tubes of incontinence (buttons).
Exclusion Criteria
* Second session: First review: Otoscopy / Timpneometry / Hearing test.
* Parallel treatment: acupuncture - tubes insertion - discontinuation of follow-up - cessation of the experiment initiated by parents
4 Years
10 Years
ALL
No
Sponsors
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Yuinvent Innovations Ltd.
INDUSTRY
Responsible Party
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Other Identifiers
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0275-18-MMC (CLEAR OM R1)
Identifier Type: -
Identifier Source: org_study_id
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