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NCT03978195 Clinical Trial

A Non-invasive Device to Remove Fluid From the Middle Ear

Otitis Media With Effusion Clinical Trial

Official title:
EMD - A Non-invasive Device for Ventilating the Middle Ear Feasibility Study to Evaluate Efficiency and User Satisfaction

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03978195
Other study ID # 0275-18-MMC (CLEAR OM R1)
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2019
Est. completion date November 1, 2021

Study information
Verified date June 2019
Source Yuinvent Innovations Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 40
Est. completion date November 1, 2021
Est. primary completion date August 1, 2021
Accepts healthy volunteers No
Gender All
Age group 4 Years to 10 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Non-invasive device for middle ear ventilation
Daily use of the device

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Yuinvent Innovations Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary Middle ear values of Tympanometry Values will be compared to baseline values of Tympanometry 10 weeks
Primary Middle ear ventilation evaluated by otoscopy Otoscopy evaluation of ear ventilation will be compared to baseline values 10 weeks
Secondary Auditory test Values will be compared to baseline values of Auditory test 10 weeks
See also
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Not yet recruiting NCT03491098 - The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study Early Phase 1
Completed NCT01082029 - Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children Phase 4
Completed NCT00939796 - Clinical Study of the Tympanostomy Tube Delivery System N/A
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Recruiting NCT02215681 - Acupuncture Effect on Inflammatory Markers in Pediatric Otitis Media With Effusion: A Pilot Study N/A