Back to resultsA Non-invasive Device to Remove Fluid From the Middle Ear
Primary Purpose
Otitis Media With Effusion
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Non-invasive device for middle ear ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media With Effusion
Eligibility Criteria
Inclusion Criteria:
- 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.
- 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:
- First encounter: acute ear infection or Proper Otoscopy
- Second session: First review: Otoscopy / Timpneometry / Hearing test.
- Parallel treatment: acupuncture - tubes insertion - discontinuation of follow-up - cessation of the experiment initiated by parents
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Outcomes
Primary Outcome Measures
Middle ear values of Tympanometry
Values will be compared to baseline values of Tympanometry
Middle ear ventilation evaluated by otoscopy
Otoscopy evaluation of ear ventilation will be compared to baseline values
Secondary Outcome Measures
Auditory test
Values will be compared to baseline values of Auditory test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03978195
Brief Title
A Non-invasive Device to Remove Fluid From the Middle Ear
Official Title
EMD - A Non-invasive Device for Ventilating the Middle Ear Feasibility Study to Evaluate Efficiency and User Satisfaction
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
November 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuinvent Innovations Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
A feasibility study for evaluating efficacy and satisfaction is treated using a non-invasive device for middle ear ventilation.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Non-invasive device for middle ear ventilation
Intervention Description
Daily use of the device
Primary Outcome Measure Information:
Title
Middle ear values of Tympanometry
Description
Values will be compared to baseline values of Tympanometry
Time Frame
10 weeks
Title
Middle ear ventilation evaluated by otoscopy
Description
Otoscopy evaluation of ear ventilation will be compared to baseline values
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Auditory test
Description
Values will be compared to baseline values of Auditory test
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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:
First encounter: acute ear infection or Proper Otoscopy
Second session: First review: Otoscopy / Timpneometry / Hearing test.
Parallel treatment: acupuncture - tubes insertion - discontinuation of follow-up - cessation of the experiment initiated by parents
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Non-invasive Device to Remove Fluid From the Middle Ear
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